Revised Medical Criteria for Evaluating Digestive Disorders and Skin Disorders, 35936-35958 [2019-15554]

Download as PDF 35936 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules SOCIAL SECURITY ADMINISTRATION 20 CFR Part 404 [Docket No. SSA–2017–0042] RIN 0960–AG65 Revised Medical Criteria for Evaluating Digestive Disorders and Skin Disorders Social Security Administration. Notice of proposed rulemaking. AGENCY: ACTION: We propose to revise the criteria in the Listing of Impairments (listings) that we use to evaluate claims involving digestive and skin disorders in adults and children under titles II and XVI of the Social Security Act (Act). The proposed revisions reflect our adjudicative experience, advances in medical knowledge, and comments we received from experts and the public in response to two advance notices of proposed rulemaking (ANPRM). DATES: To ensure that your comments are considered, we must receive them by no later than September 23, 2019. ADDRESSES: You may submit comments by any one of three methods—internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA–2017–0042, so that we may associate your comments with the correct regulation. Caution: You should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social Security numbers or medical information. 1. Internet: We strongly recommend that you submit your comments via the internet. Please visit the Federal eRulemaking portal at http:// www.regulations.gov. Use the Search function to find docket number SSA– SUMMARY: 2017–0042. The system will issue a tracking number to confirm your submission. You will not be able to view your comment immediately because we must post each comment manually. It may take up to a week for your comment to be viewable. 2. Fax: Fax comments to (410) 966– 2830. 3. Mail: Address your comments to the Office of Regulations and Reports Clearance, Social Security Administration, 3100 West High Rise, 6401 Security Boulevard, Baltimore, Maryland 21235–6401. Comments are available for public viewing on the Federal eRulemaking portal at http://www.regulations.gov or in person, during regular business hours, by arranging with the contact person identified below. FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, Baltimore, Maryland 21235–6401, (410) 965–1020. For information on eligibility or filing for benefits, call our national toll-free number, 1–800–772–1213, or TTY 1– 800–325–0778, or visit our internet site, Social Security Online, at http:// www.socialsecurity.gov. SUPPLEMENTARY INFORMATION: Why are we proposing to revise the listings for digestive and skin disorders? We last published final rules that revised the digestive disorders listings on October 19, 2007, and the skin disorders listings on June 9, 2004.1 We are proposing these revisions to reflect our adjudicative experience, advances in medical knowledge, and comments we received from experts and the public in response to two ANPRMs. How did we develop these proposed rules? In developing these proposed rules: • We published an ANPRM for digestive disorders in the Federal Current sections of the adult introductory text and listings for the digestive system Register on December 12, 2007.2 We invited the public to comment on whether we should add a digestive disorders listing based on functional limitations and, if so, what criteria we should use. We received 12 comments. Ten commenters recommended adding a digestive disorders listing with functional criteria and suggested we use the same functional criteria we use in other body systems. • We published an ANPRM for skin disorders in the Federal Register on November 10, 2009.3 We invited the public to send us written comments and suggestions about whether and how we should revise the skin disorders listings. We received three comments. The comments we received from these two ANPRMs informed the proposed changes in this NPRM. In developing these proposed rules, we also considered information from several other sources, including: • Medical experts in gastroenterology and dermatology; • Advocacy groups for people with digestive and skin disorders; • People with digestive and skin disorders and their families; • People who make and review disability determinations and decisions for us in State agencies, in our Office of Hearings Operations, and in our Office of Analytics, Review, and Oversight; and • The published sources we list in the References section at the end of this preamble. How is this NPRM organized? Digestive Disorders Overview of Proposed Revisions • Adult digestive disorders proposed revisions • Child digestive disorders proposed revisions The following chart shows the heading of the current and proposed sections of the adult introductory text and listings for digestive disorders: Proposed sections of the adult introductory text and listings for digestive disorders jspears on DSK30JT082PROD with PROPOSAL10 Introductory Text, 5.00 A. What kinds of disorders do we consider in the digestive system? ..... B. What documentation do we need? ...................................................... C. How do we consider the effects of treatment? ................................... D. How do we evaluate chronic liver disease? ........................................ E. How do we evaluate inflammatory bowel disease (IBD)? ................... F. How do we evaluate short bowel syndrome (SBS)? ........................... 1 See 72 FR 59398 (2007) and 69 FR 32260 (2004). VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 PO 00000 2 See A. Which digestive disorders do we evaluate in this body system? B. What evidence do we need to evaluate your digestive disorder? [5.00 H.] C. What is chronic liver disease (CLD), and how do we evaluate it under 5.05? D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 5.06? E. What is short bowel syndrome (SBS), and how do we evaluate it under 5.07? 72 FR 70527. Frm 00002 Fmt 4701 3 See 74 FR 57972, with the docket number corrected at 74 FR 62518. Sfmt 4702 E:\FR\FM\25JYP2.SGM 25JYP2 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules 35937 Current sections of the adult introductory text and listings for the digestive system Proposed sections of the adult introductory text and listings for digestive disorders G. How do we evaluate weight loss due to any digestive disorder? ....... F. How do we evaluate malnutrition due to any digestive disorder under 5.08? G. How do we evaluate digestive organ transplantation? [5.00 C.2. and G.] [5.00 D.12.] ............................................................................................... H. What do we mean by the phrase ‘‘consider under a disability for 1 year’’? [5.00 C.6.] ................................................................................................. I. How do we evaluate impairments that do not meet one of the digestive disorder listings? H. How do we evaluate your digestive disorder if there is no record of ongoing treatment? I. How do we evaluate your digestive disorder if there is evidence establishing a substance use disorder? J. How do we evaluate digestive disorders that do not meet one of these listings? Listings 5.01 Category of Impairments, Digestive System ................................. 5.02 Gastrointestinal hemorrhaging from any cause, requiring blood transfusion. 5.03 [Reserved] ...................................................................................... 5.04 [Reserved] ...................................................................................... 5.05 Chronic liver disease (CLD) ........................................................... 5.06 Inflammatory bowel disease (IBD) ................................................. 5.07 Short bowel syndrome (SBS) ........................................................ 5.08 Weight loss due to any digestive disorder .................................... 5.09 Liver transplantation ....................................................................... The following chart shows the heading of the current and proposed 5.01 Category of Impairments, Digestive Disorders 5.02 Gastrointestinal hemorrhaging from any cause, requiring three blood transfusions 5.03 [Reserved] 5.04 [Reserved] 5.05 Chronic liver disease (CLD) 5.06 Inflammatory bowel disease (IBD) 5.07 Short bowel syndrome (SBS) 5.08 Malnutrition due to any digestive disorder 5.09 Liver transplantation 5.10 [Reserved] 5.11 Small intestine transplantation 5.12 Pancreas transplantation sections of the child introductory text and listings for digestive disorders: Current sections of the child introductory text and listings for the digestive system Proposed sections of the child introductory text and listings for digestive disorders Introductory Text, 105.00 A. What kinds of disorders do we consider in the digestive system? ..... B. What documentation do we need? ...................................................... C. How do we consider the effects of treatment? ................................... D. How do we evaluate chronic liver disease? ........................................ E. How do we evaluate inflammatory bowel disease (IBD)? ................... F. How do we evaluate short bowel syndrome (SBS)? ........................... G. How do we evaluate growth failure due to any digestive disorder? ... [105.00 D.13.] ........................................................................................... H. How do we evaluate the need for supplemental daily enteral feeding via a gastrostomy? I. How do we evaluate esophageal stricture or stenosis? ....................... J. What do we mean by the phrase ‘‘consider under a disability for 1 year’’? [105.00 C.6.] ............................................................................................. K. How do we evaluate impairments that do not meet one of the digestive disorder listings? A. Which digestive disorders do we evaluate in this body system? B. What evidence do we need to evaluate your digestive disorder? [105.00 J.] C. What is chronic liver disease (CLD), and how do we evaluate it under 105.05? D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 105.06? E. What is short bowel syndrome (SBS), and how do we evaluate it under 105.07? F. How do we evaluate growth failure due to any digestive disorder under 105.08? G. How do we evaluate digestive organ transplantation? H. How do we evaluate the need for supplemental daily enteral feeding via a gastrostomy? I. How do we evaluate esophageal stricture or stenosis? [105.00 C.2., C.4., and G.] J. How do we evaluate your digestive disorder if there is no record of ongoing treatment? K. How do we evaluate your digestive disorder if there is evidence establishing a substance use disorder? L. How do we evaluate digestive disorders that do not meet one of these listings? jspears on DSK30JT082PROD with PROPOSAL10 Listings 105.01 Category of Impairments, Digestive System ............................. 105.02 Gastrointestinal hemorrhaging from any cause, requiring blood transfusion. 105.03 [Reserved] .................................................................................. 105.04 [Reserved] .................................................................................. 105.05 Chronic liver disease ................................................................. 105.06 Inflammatory bowel disease (IBD) ............................................. 105.07 Short bowel syndrome (SBS) .................................................... 105.08 Growth failure due to any digestive disorder ............................. VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 PO 00000 Frm 00003 Fmt 4701 105.01 105.02 blood 105.03 105.04 105.05 105.06 105.07 105.08 Sfmt 4702 Category of Impairments, Digestive Disorders Gastrointestinal hemorrhaging from any cause, requiring three transfusions [Reserved] [Reserved] Chronic liver disease (CLD) Inflammatory bowel disease (IBD) Short bowel syndrome (SBS) Growth failure due to any digestive disorder E:\FR\FM\25JYP2.SGM 25JYP2 35938 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules Current sections of the child introductory text and listings for the digestive system 105.09 105.10 Proposed sections of the child introductory text and listings for digestive disorders Liver transplantation ................................................................... Need for supplemental daily enteral feeding via a gastrostomy Skin Disorders Overview of Proposed Revisions • Adult skin disorders proposed revisions 105.09 Liver transplantation 105.10 Need for supplemental daily enteral feeding via a gastrostomy 105.11 Small intestine transplantation 105.12 Pancreas transplantation • Child skin disorders proposed revisions The following chart shows the heading of the current and proposed Current sections of the adult introductory text and listings for the skin disorders sections of the adult introductory text and listings for skin disorders: Proposed sections of the adult introductory text and listings for skin disorders Introductory Text, 8.00 A. What skin disorders do we evaluate with these listings? .................... B. What documentation do we need? ...................................................... C. How do we assess the severity of your skin disorder(s)? .................. D. How do we assess impairments that may affect the skin and other body systems? E. How do we evaluate genetic photosensitivity disorders? .................... F. How do we evaluate burns? ................................................................ G. How do we determine if your skin disorder(s) will continue at a disabling level of severity in order to meet the duration requirement? H. How do we assess your skin disorder(s) if your impairment does not meet the requirements of one of these listings? I. ................................................................................................................ A. Which skin disorders do we evaluate under these listings? B. What are our definitions for the following terms used in this body system? C. What evidence do we need to evaluate your skin disorder? D. How do we evaluate the severity of skin disorders? E. How do we evaluate genetic photosensitivity disorders under 8.07? F. How do we evaluate burns under 8.08? G. How do we evaluate chronic conditions of the skin or mucous membranes under 8.09? H. How do we evaluate disorders in other body systems that affect the skin? I. How do we evaluate skin disorders that do not meet one of these listings? Listings 8.01 8.02 8.03 8.04 8.05 8.06 8.07 8.08 Category of Impairments, Skin Disorders ...................................... Ichthyosis ....................................................................................... Bullous disease .............................................................................. Chronic infections of the skin or mucous membranes .................. Dermatitis ....................................................................................... Hidradenitis suppurativa ................................................................ Genetic photosensitivity disorders ................................................. Burns .............................................................................................. The following chart shows the heading of the current and proposed 8.01 8.02 8.03 8.04 8.05 8.06 8.07 8.08 8.09 Category of Impairments, Skin Disorders [Reserved] [Reserved] [Reserved] [Reserved] [Reserved] Genetic photosensitivity disorders Burns Chronic conditions of the skin or mucous membranes sections of the child introductory text and listings for skin disorders: Current sections of the child introductory text and listings for the skin disorders Proposed sections of the child introductory text and listings for skin disorders Introductory Text, 108.00 A. What skin disorders do we evaluate with these listings? .................... B. What documentation do we need? ...................................................... jspears on DSK30JT082PROD with PROPOSAL10 C. How do we assess the severity of your skin disorder(s)? .................. D. How do we assess impairments that may affect the skin and other body systems? E. How do we evaluate genetic photosensitivity disorders? .................... F. How do we evaluate burns? ................................................................ G. How do we determine if your skin disorder(s) will continue at a disabling level of severity in order to meet the duration requirement? H. How do we assess your skin disorder(s) if your impairment does not meet the requirements of one of these listings? I. ................................................................................................................ A. Which skin disorders do we evaluate under these listings? B. What are our definitions for the following terms used in this body system? C. What evidence do we need to evaluate your skin disorder? D. How do we evaluate the severity of skin disorders? E. How do we evaluate genetic photosensitivity disorders under 108.07? F. How do we evaluate burns under 108.08? G. How do we evaluate chronic conditions of the skin or mucous membranes under 108.09? H. How do we evaluate disorders in other body systems that affect the skin? I. How do we evaluate skin disorders that do not meet one of these listings? Listings 108.01 Category of Impairments, Skin Disorders .................................. VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 PO 00000 Frm 00004 Fmt 4701 108.01 Sfmt 4702 Category of Impairments, Skin Disorders E:\FR\FM\25JYP2.SGM 25JYP2 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules Current sections of the child introductory text and listings for the skin disorders 108.02 108.03 108.04 108.05 108.06 108.07 108.08 Proposed 5.00—Introductory Text to the Adult Digestive Disorders Listings The following describes changes we are proposing to the introductory text. jspears on DSK30JT082PROD with PROPOSAL10 Proposed sections of the child introductory text and listings for skin disorders Ichthyosis ................................................................................... Bullous disease .......................................................................... Chronic infections of the skin or mucous membranes .............. Dermatitis ................................................................................... Hidradenitis suppurativa ............................................................ Genetic photosensitivity disorders ............................................. Burns .......................................................................................... What revisions are we proposing for digestive disorders? We propose to: • Change the name of the body system from ‘‘Digestive System’’ to ‘‘Digestive Disorders’’ to be consistent with the nomenclature of all body systems; • Revise and reorganize the introductory text to provide guidance for using the revised criteria in listings; • Revise the SSA Chronic Liver Disease (SSA CLD) score in listings 5.05 and 105.05; • Add criteria to listings 5.06 and 105.06 for repeated complications of IBD; • Add adult and child listings for small intestine transplantation (proposed 5.11 and 105.11) and pancreas transplantation (proposed 5.12 and 105.12); and • Make minor editorial revisions to the introductory text and listings for clarity. Proposed 5.00C—What is chronic liver disease (CLD), and how do we evaluate it under 5.05? We propose to: • Redesignate current 5.00C (How do we consider the effects of treatment?) as proposed 5.00H and remove some of the guidance in current 5.00C (paragraphs 1 through C4) because the guidance is a restatement of general policy on how we consider the effects of treatment that is not unique to digestive disorders but applicable to all medically determinable impairments; • Redesignate current 5.00D (How do we evaluate chronic liver disease?) as proposed 5.00C; • Remove the discussion of hepatitis B and C in current 5.00D4 (Chronic viral hepatitis infections) because it does not contain guidance on evaluating CLD and continue to evaluate CLD resulting from hepatitis B and C under proposed listing 5.05; • In 5.00C2, incorporate the information about CLD manifestations VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 108.02 108.03 108.04 108.05 108.06 108.07 108.08 108.09 [Reserved] [Reserved] [Reserved] [Reserved] [Reserved] Genetic photosensitivity disorders Burns Chronic conditions of the skin or mucous membranes that is in current 5.00D3 (Manifestations of chronic liver disease) and 5.00D5 through 5.00D10 (Gastrointestinal hemorrhage, Ascites or hydrothorax, Spontaneous bacterial peritonitis, Hepatorenal syndrome, Hepatopulmonary syndrome, and Hepatic encephalopathy), provide guidance on how to assess the severity of these manifestations, and include the guidance in current 5.00H (What do we mean by the phrase ‘‘consider under a disability for 1 year’’?); and • In 5.00C3, incorporate the information about the SSA CLD score calculation in current 5.00D11 (End stage liver disease (ESLD) documented by scores from the SSA Chronic Liver Disease (SSA CLD) calculation) and add an SSA CLD calculation example. Proposed 5.00D—What is inflammatory bowel disease (IBD), and how do we evaluate it under 5.06? We propose to redesignate current 5.00E (How do we evaluate inflammatory bowel disease?) as proposed 5.00D. We would describe the factors we consider when we evaluate impaired functioning due to IBD under proposed 5.06C. We would also define ‘‘marked’’ limitation and explain the three areas of functioning we use in the proposed listing. Proposed 5.00E—What is short bowel syndrome (SBS), and how do we evaluate it under 5.07? We propose to redesignate current 5.00F (How do we evaluate short bowel syndrome?) as proposed 5.00E. We would also remove text about long-term complications of SBS because this content, while not incorrect, is not necessary to understand in order to evaluate SBS under 5.07. Proposed 5.00F—How do we evaluate malnutrition due to any digestive disorder under 5.08? We propose to redesignate current 5.00G (How do we evaluate weight loss due to any digestive disorder?) as proposed 5.00F. We would also use the term ‘‘malnutrition’’ instead of ‘‘weight loss,’’ and clarify that weight loss must PO 00000 Frm 00005 35939 Fmt 4701 Sfmt 4702 be the result of malnutrition caused by a digestive disorder. Proposed 5.00G—How do we evaluate digestive organ transplantation? We propose to incorporate the guidance in current 5.00D12 (Liver transplantation), and the guidance in 5.00H (What do we mean by the phrase ‘‘consider under a disability for 1 year’’?), in proposed 5.00G. Proposed 5.00H—How do we evaluate your digestive disorder if there is no record of ongoing treatment? In proposed 5.00H, we incorporate the guidance in current 5.00C6, which explains what we do when there is no record of ongoing treatment. As we explained earlier, we removed the guidance in current 5.00C (paragraphs 1 through 4) because this the guidance is a restatement of general policy on how we consider the effects of treatment that is not unique to digestive disorders but applicable to all medically determinable impairments. Proposed 5.00I—How do we evaluate your digestive disorder if there is evidence establishing a substance use disorder? In proposed 5.00I, we incorporate by reference our regulations for determining whether drug addiction or alcoholism is a contributing factor material to the determination of disability because use of drugs or alcohol may result in a chronic digestive disorder, such as drug-induced hepatitis or alcoholic liver disease. Proposed 5.00J—How do we evaluate digestive disorders that do not meet one of these listings? We propose to redesignate current 5.00I (How do we evaluate impairments that do not meet one of the digestive disorder listings?) as proposed 5.00J. Proposed Changes to the Adult Digestive Disorders Listings Proposed Listing 5.02—Gastrointestinal Hemorrhaging From Any Cause We propose to change the period during which the criteria in listing 5.02 E:\FR\FM\25JYP2.SGM 25JYP2 35940 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules must occur from a ‘‘6-month period’’ to a ‘‘12-month period’’ to be consistent with the timeframe criteria in all other body systems within the listings. jspears on DSK30JT082PROD with PROPOSAL10 Proposed Listing 5.05—Chronic Liver Disease (CLD) In 5.05A, we propose to clarify the requirement for documenting hemodynamic instability by moving the list of signs of hemodynamic instability from current 5.00D5 (Gastrointestinal hemorrhage) to proposed 5.05A. In 5.05B (Ascites or hydrothorax), we propose to change the period during which ascites or hydrothorax must occur from a ‘‘6-month period’’ to a ‘‘12month period’’ to be consistent with the timeframe criteria in all other body systems within the listings. In 5.05E1 (Hepatopulmonary syndrome documented by arterial PaO2), we propose to add ‘‘measured by an ABG test, while at rest, breathing room air, less than or equal to’’ to clarify our requirements for a PaO2 measurement. In 5.05G (SSA CLD scores), we propose to change the SSA CLD score requirement from ‘‘22 or greater’’ to ‘‘at least 20.’’ A score of at least 20 accurately identifies advanced, end stage liver disease that will prevent a person from engaging in any gainful activity or will lead to death.4 5 6 7 We also propose to remove the term ‘‘end stage liver disease’’ because the evidence we require in order for us to consider chronic liver disease under 5.05G does not need to include the term ‘‘end stage liver disease’’ (which may also be referred to as ‘‘chronic liver failure’’). digestive disorder). In 5.06A (Obstruction of stenotic areas) and 5.06B (Combination of clinical findings), we propose to change the period during which the listing criteria must occur from a ‘‘6-month period’’ to a ‘‘12month period’’ to be consistent with the timeframe criteria in all other body systems within the listings. We also propose to add a criterion (proposed 5.06C) for repeated complications of IBD that result in marked limitation in at least one area of functioning. These criteria characterize complications of IBD that prevent a person from engaging in any gainful activity.8 9 10 11 This proposed listing combines medical criteria with specific limitations in functioning to identify IBD of listing-level severity. The addition of functional criteria is also consistent with the listings that already include these same functional criteria, which are 7.18 (Repeated complications of hematological disorders), 14.02B (Repeated manifestations of systemic lupus erythematosus), 14.04D (Repeated manifestations of systemic sclerosis), 14.05E (Repeated manifestations of polymyositis or dermatomyositis), 14.06B (Repeated manifestations of undifferentiated or mixed connective tissue disease), 14.07C (Repeated manifestations of an immune deficiency disorder), 14.09D (Repeated manifestations of inflammatory arthritis), 14.10B (Sjo¨gren’s syndrome), and 14.11I (Repeated manifestations of HIV infection). Proposed Listing 5.07—Short Bowel Syndrome (SBS) Proposed Listing 5.06—Inflammatory Bowel Disease (IBD) We propose to remove the low hemoglobin, low serum albumin, and weight loss criteria, which indicate malnutrition, in current 5.06 because we will evaluate those criteria under proposed 5.08 (Malnutrition due to any We propose to require ‘‘surgical resection of any amount of the small intestine’’ instead of ‘‘surgical resection of more than one-half of the small intestine’’ because measurement of the total length of remaining intestine within the abdominal cavity is rarely obtained during surgery.12 13 14 4 Annamalai, A., Harada, M., Chen, M., Tran, T., Ko, A., Ley, E., . . . Noureddin, M. (2016). Predictors of mortality in the critically ill cirrhotic patient: Is the model for end-stage liver disease enough? Journal of the American College of Surgeons, 224(3), 276–282. doi:10.1016/ j.jamcollsurg.2016.11.005. 5 Zhiang, E., Zhang, Z., Want, S., Xiao, Z., Gu, J., Xiong, M., . . . Huang, Z. (2016). Predicting the severity of liver cirrhosis through clinical parameters. Journal of Surgical Research, 204(2), 274–281. doi:10.1016/j.jss.2016.04.036. 6 Singal, A.K. & Kamath, P.S. (2013). Model for end-stage liver disease. Journal of Clinical and Experimental Hepatology, 3(1), 50–60. doi:10.1016/ j.jceh.2012.11.002. 7 Bittermann, T., Makar, G., & Goldberg, D.S. (2015). Early post-transplant survival: Interaction of MELD score and hospitalization status. Journal of Hepatology, 63(3), 601–608. doi:10.1016/ j.jhep.2015.03.034. 8 Farraye, F.A., Melmed, G.Y., Lichtenstein, G.R., & Kane, S.V. (2017). ACG clinical guidelines: Preventative care in inflammatory bowel disease. American Journal of Gastroenterology, 112(2), 241– 258. 9 Gajendran, M., Loganathan, P., Catinella, A.P., & Hashash, J.G. (2018). A comprehensive review and update on Crohn’s disease. Disease-a-Month, 64, 20–57. 10 Rubin, D.T., Ananthakrishnan, A.N., Siegel, C.A., Sauer, B.G., & Long, M.D. (2019). ACG clinical guidelines: Ulcerative colitis in adults. American Journal of Gastroenterology, 114(3), 384–413. 11 Yarur, A.J., Strobel, S.G., Deshpande, A.R., & Abreu, M.T. (2011). Predictors of aggressive inflammatory bowel disease. Gastroenterology & Hepatology, 7(10), 652–659. 12 Eca, R. & Barbosa, E. (2016). Short bowel syndrome: treatment options. Journal of Coloproctology, 36(4), 262–272. doi:10.1016/ j.jcol.2013.07.002. VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 Proposed Listing 5.08—Malnutrition Due to Any Digestive Disorder We propose to revise the heading of current 5.08 from ‘‘Weight loss due to any digestive disorder’’ to ‘‘Malnutrition due to any digestive disorder,’’ and revise the body mass index (BMI) measurement from ‘‘less than 17.5’’ to ‘‘less than 18.0.’’ We also propose to include the criteria for low hemoglobin, low serum albumin, and the need for supplemental daily enteral or parenteral nutrition, which are in current 5.06B. These criteria are findings indicative of malnutrition, which may result from any digestive disorder, not just IBD. The combination of low BMI measurements and one of these other findings improves the specificity of listing 5.08.15 Lastly, we propose to change the period during which the listing criteria must occur from a ‘‘6-month period’’ to a ‘‘12-month period’’ to be consistent with the timeframe criteria in all other body systems within the listings. Proposed Digestive Organ Transplantation Listings We propose to add listing 5.11 for small intestine transplantation and listing 5.12 for pancreas transplantation.16 17 We currently evaluate small intestine and pancreas transplantations under listing 5.09 for liver transplantation using our medical equivalence rules. The separate listings would allow us to differentiate which digestive organ has been transplanted and allow us to propose future updates to each separate listing, as needed, based on medical advances in the specific organ transplant category. 13 Hommel, M.J., van Baren, R., & Haveman, J.W. (2016). Surgical management and autologous intestinal reconstruction in short bowel syndrome. Best Practice & Research Clinical Gastroenterology, 30(2), 263–280. doi:10.1016/j.bpg.2016.03.006. 14 Wong, T. & Gupte, G. (2015). Complications of short bowel syndrome. Paediatrics and Child Health, 25(9), 418–421. doi:10.1016/ j.paed.2015.07.001. 15 Naldi, M., Baldassarre, M., Domenicali, M., Bartolini, M., & Caraceni, P. (2017). Structural and functional integrity of human serum albumin: Analytical approaches and clinical relevance in patients with liver cirrhosis. Journal of Pharmaceutical and Biomedical Analysis, 144, 138– 153. doi.org/10.1016/j.jpba.2017.04.023. 16 Dholakia, S., Mittal, S., Quiroga, I., Gilbert, J., Sharples, E.J., Ploeg, R.J., & Friend, P.J. (2016). Pancreas transplantation: Past, present, future. The American Journal of Medicine, 129(7), 667–673. doi:10.1016/j.amjmed.2016.02.011. 17 Hommel, M.J., van Baren, R., & Haveman, J.W. (2016). Surgical management and autologous intestinal reconstruction in short bowel syndrome. Best Practice & Research Clinical Gastroenterology, 30(2), 263–280. doi:10.1016/j.bpg.2016.03.006. E:\FR\FM\25JYP2.SGM 25JYP2 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules Proposed 105.00—Introductory Text to the Child Digestive Disorders Listings We repeat much of the introductory text of proposed 5.00 in the introductory text of proposed 105.00. This repetition is because the same basic rules apply for evaluating digestive disorders in adults and in children. Proposed Changes to the Child Digestive Disorders Listings We are proposing changes in the child listings to correspond with the changes we are proposing in the adult listings. The reasons we gave earlier for changing or removing current criteria for adults also apply to the criteria for children. Additionally, the numbering of the child listings would conform to the adult listings. jspears on DSK30JT082PROD with PROPOSAL10 What revisions are we proposing for skin disorders? We propose to: • Revise and reorganize the introductory text to provide guidance for using the revised criteria in listings; • Remove and reserve current adult listings 8.02 (Ichthyosis), 8.03 (Bullous disease), 8.04 (Chronic infections of the skin or mucous membranes), 8.05 (Dermatitis), and 8.06 (Hidradenitis suppurativa) and consolidate the current criteria into one listing for chronic conditions of the skin or mucous membranes (proposed 8.09), and remove and reserve current child listings 108.02 (Ichthyosis), 108.03 (Bullous disease), 108.04 (Chronic infections of the skin or mucous membranes), 108.05 (Dermatitis), and 108.06 (Hidradenitis suppurativa) and consolidate the current criteria into one listing for chronic conditions of the skin or mucous membranes (proposed 108.09), to strengthen adjudicative ease and more efficiently capture adults and children with skin disorders of listinglevel severity; • Include limitations of physical functioning we use to assess impairment severity, which are explained in current 8.00C and 108.00C (How do we assess the severity of your skin disorder(s)?), in the listing criteria for adult listings 8.07B (Other genetic photosensitivity disorders), 8.08 (Burns), and 8.09 (Chronic conditions of the skin or mucous membranes) and child listings 108.07B (Other genetic photosensitivity disorders), 108.08 (Burns), and 108.09 (Chronic conditions of the skin or mucous membranes); and • Make minor editorial revisions to the introductory text and listings for clarity. VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 Proposed 8.00—Introductory Text to the Adult Skin Disorders Listings Most of the guidance in the proposed introductory text is substantively the same as the guidance in the current introductory text. The following is a detailed description of the significant changes we are proposing to the introductory text. In addition to the changes we describe below, we are proposing other, minor changes to the introductory text to clarify how we use the proposed listings to evaluate skin disorders. Proposed 8.00B—What are our definitions for the following terms used in this body system? In this new section, 8.00B, we provide definitions for terms, such as ‘‘chronic skin lesions’’ and ‘‘contractures,’’ that we use in the listings to evaluate skin disorders. Proposed 8.00C—What evidence do we need to evaluate your skin disorder? In 8.00C, we incorporate the guidance in current 8.00B (What documentation do we need?). Proposed 8.00D—How do we evaluate the severity of skin disorders? In 8.00D, we discuss how we evaluate the severity of skin disorders (which is now contained in current 8.00C) and add a clearer explanation for how we quantify limitations in functioning under these listings. In 8.00D1, we explain how we evaluate the severity of skin disorders based on the site(s) of the lesions or contractures and the response to treatment. In 8.00D2, we explain the functional criteria we use to evaluate skin disorders under proposed 8.07B (Other genetic photosensitivity disorders), 8.08 (Burns), and 8.09 (Chronic conditions of the skin or mucous membranes). Chronic skin lesions or contractures may restrict movement and result in limitation(s) of physical functioning (ability to use the upper extremities, stand up from a seated position, or maintain an upright position while standing or walking). In 8.00D3, we propose to replace the term ‘‘flare-ups’’ with ‘‘exacerbations.’’ In 8.00D4, we propose to incorporate the guidance on symptoms in current 8.00C3 (Symptoms (including pain)). In 8.00D5, we propose to incorporate and revise the guidance on treatment in current 8.00D4 (Disfigurement or deformity) and 8.00G (How do we determine if your skin disorder(s) will continue at a disabling level of severity in order to meet the duration requirement?). We propose to replace the term ‘‘continuing treatment as prescribed’’ with ‘‘adherence to PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 35941 prescribed medical treatment’’ to be consistent with current medical terminology. In 8.00D5b, we provide guidance on how to evaluate skin disorders after adherence to prescribed medical treatment for 3 months. In 8.00D5c, we provide guidance on how to evaluate claims in which the prescribed medical treatment is psoralen and ultraviolet A light (PUVA) or biologics. PUVA is a treatment involving exposure to UVA light after taking a biologic medication called psoralen that increases the skin’s sensitivity to ultraviolet light. PUVA is generally used under medical supervision when other conservative treatments for skin disorders have proven to be ineffective.18 19 20 21 We explain that, if a person receives PUVA or biologics, we will defer adjudication until 6 months from the start of treatment unless we can make a fully favorable determination or decision on another basis. In 8.00D6, we clarify how we evaluate cases in which there is no longitudinal record of ongoing treatment. Proposed 8.00E—How do we evaluate genetic photosensitivity disorders under 8.07? In 8.00E3, we explain that we will not purchase genetic testing, but will consider the results of this testing if it is in a person’s case record. In 8.00E4, we include what the phrase ‘‘inability to function outside of a highly protective environment’’ means, which is in current 8.00E2 (Other genetic photosensitivity disorders). Proposed 8.00F—How do we evaluate burns under 8.08? In 8.00F, we include guidance for evaluating third-degree burns resulting in contractures that have been documented by an acceptable medical source to have reached maximum therapeutic benefit. 18 Farahnik, B., Nakamura, M., Singh, R.K., Abrouk, M., Zhu, T.H., Lee, K.M., . . . Liao, W. (2016). The patient’s guide to psoriasis treatment. Part 2: PUVA phototherapy. Dermatology and Therapy, 6(3), 315–324. doi:10.1007/s13555–016– 0130–9. 19 Ong, S., & Venning, V. (2014). PUVA treatment information for patients. Retrieved from Oxford University Hospital NHS website: https:// www.ouh.nhs.uk/patient-guide/leaflets/files/ 120719puva.pdf. 20 Shenoi, S.D., & Prabhu, S. (2014). Photochemotherapy (PUVA) in psoriasis and vitiligo. Indian Journal of Dermatology, Venereology and Leprology, 80(6), 497–504. doi:10.4103/0378– 6323.144143. 21 Weber, F., Schmuth, M., Seep, N., & Fritsch, P. (2005). Bath-water PUVA therapy with 8methoxypsoralen in mycosis fungoides. Acta Dermato-Venereologica, 85, 329–332. doi:10.1080/ 00015550510032814. E:\FR\FM\25JYP2.SGM 25JYP2 35942 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules Proposed 8.00G—How do we evaluate chronic conditions of the skin or mucous membranes under 8.09? In 8.00G, we provide examples of the skin disorders we evaluate under new listing 8.09, which include ichthyosis, bullous diseases, chronic skin infections, dermatitis, and hidradenitis suppurativa. Proposed 8.00H—How do we evaluate disorders in other body systems that affect the skin? In 8.00H, we include the guidance in current 8.00D (How do we assess impairments that may affect the skin and other body systems?). We also propose to include a new paragraph (8.00H1) on evaluating skin disorders that are complications of diabetes mellitus. Proposed 8.00I—How do we evaluate skin disorders that do not meet one of these listings? In 8.00I, we include the guidance in current 8.00H (How do we assess your skin disorder(s) if your impairment does not meet the requirements of one of these listings?). Proposed Changes to the Adult Skin Disorders Listings Proposed Listing 8.07—Genetic Photosensitivity Disorders We propose to include the functional criteria, which we explain above, directly in 8.07B to evaluate limitation of physical functioning due to a genetic photosensitivity disorder. In some cases, this requirement may be overlooked by adjudicators because the functional criteria are not currently included as listing criteria, but rather are explained in the introductory text. Proposed Listing 8.08—Burns We propose to include the functional criteria, which we explain above, directly in 8.08 to evaluate limitation of physical functioning due to burns. In some cases, this requirement may be overlooked by adjudicators because the functional criteria are not currently included as listing criteria, but rather are explained in the introductory text. jspears on DSK30JT082PROD with PROPOSAL10 Proposed Listing 8.09—Chronic Conditions of the Skin or Mucous Membranes We propose to remove and reserve current listings 8.02 (Ichthyosis), 8.03 (Bullous disease), 8.04 (Chronic infections of the skin or mucous membranes), 8.05 (Dermatitis), and 8.06 (Hidradenitis suppurativa) and add listing 8.09 to evaluate these skin disorders. The criteria in the current VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 listings are identical for each type of skin disorder, and all of the named disorders are chronic conditions of the skin or mucous membranes. In proposed 8.09, we propose to include the functional criteria, which we explain above, to evaluate limitation in physical functioning due to these skin disorders. In some cases, this requirement may be overlooked by adjudicators because the functional criteria are not currently included as listing criteria, but rather are explained in the introductory text. Proposed 108.00—Introductory Text to the Child Skin Disorders Listings We repeat much of the introductory text of proposed 8.00 in the introductory text of proposed 108.00. This repetition is because the same basic rules apply for evaluating skin disorders in adults also apply to skin disorders in children with one exception—how we evaluate limitation of physical functioning. Children’s physical abilities change as they grow and mature. For example, young infants are not able to walk, but do move their extremities and may use them to roll over, crawl, or perform other functions as they develop. To evaluate the severity of skin disorders in children, we propose to use criteria based on a child’s ability to independently initiate, sustain, and complete age-appropriate activities. Proposed Changes to the Child Skin Disorders Listings We are proposing changes in the child listings to correspond with the changes we are proposing in the adult listings. Other changes are specific to how we evaluate skin disorders in children. The reasons we gave earlier for changing or removing current criteria for adults also apply to the criteria for children. Additionally, the numbering of the child listings would conform to that of the adult listings. Other Questions We are interested in receiving public comments on the following topics: • Are there any digestive or skin disorders that meet one of the proposed listings, but are generally expected to medically improve after a certain amount of time to the point at which the disorders are no longer of listing-level severity? If you believe there are digestive or skin disorders that fit into this category, please tell us by submitting your comments and any supporting research or data on that issue. • Do the proposed rules for evaluating chronic conditions of the skin or mucous membranes (conditions such as psoriasis and hidradenitis PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 suppurativa) appropriately consider whether treatment regimens interfere with the ability to do any work? If you believe the criteria should be revised, please tell us by submitting your comments and any supporting research or data. • Should any of the proposed listings for either digestive disorders or skin disorders be combined into one listing or divided into multiple listings to strengthen adjudicative ease and capture adults or children with impairments that are of listing-level severity? • Based on advances in medical functional restorative treatment of many skin disorders, is our proposal for the durations of persistent treatment appropriate for listing-level severity? Specifically, the current listings for chronic skin infections require that claimants be considered for listing-level severity if exacerbations persist despite adherence to prescribed medical treatment for three months, unless we can make a fully favorable determination or decision on another basis. We propose that, for claimants who have access to treatment with PUVA or biologics, the skin disorder be considered for listing-level severity if exacerbations persist despite treatment for six months from the start of PUVA or biologics. Alternatively, for burns, we propose that, for consideration of listing-level severity, an acceptable medical source document maximum therapeutic benefit and, therefore, a claimant is no longer receiving surgical management. Do these criteria create incentive to not seek medical treatment in order to obtain or maintain access to disability benefits? If you believe the criteria for skin disorder treatment duration should be revised, please tell us by submitting your comments and any supporting research or data. What is our authority to make rules and set procedures for determining whether a person is disabled under the statutory definition? The Act authorizes us to make rules and regulations and to establish necessary and appropriate procedures to implement them.22 How long would these proposed rules be effective? If we publish these proposed rules as final rules, they will remain in effect for 5 years after the date they become effective, unless we extend them, or revise and issue them again. 22 Sections E:\FR\FM\25JYP2.SGM 205(a), 702(a)(5), and 1631(d)(1). 25JYP2 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules Rulemaking Analyses and Notices We will consider all comments we receive on or before the close of business on the comment closing date indicated above. The comments will be available for examination in the rulemaking docket for these rules at the above address. We will file comments received after the comment closing date in the docket and will consider those comments to the extent practicable. However, we will not respond specifically to untimely comments. We may publish a final rule at any time after close of the comment period. Clarity of These Proposed Rules Executive Order 13132 (Federalism) We analyzed these proposed rules in accordance with the principles and criteria established by Executive Order 13132, and determined that these proposed rules will not have sufficient Federalism implications to warrant the preparation of a Federalism assessment. We also determined that these proposed rules will not preempt any State law or State regulation or affect the States’ abilities to discharge traditional State governmental functions. Executive Order 12866, as supplemented by Executive Order 13563, requires each agency to write all rules in plain language. In addition to your substantive comments on these proposed rules, we invite your comments on how to make them easier to understand. For example: • Would more, but shorter, sections be better? • Are the requirements in the rules clearly stated? • Have we organized the material to suit your needs? • Could we improve clarity by adding tables, lists, or diagrams? • What else could we do to make the rules easier to understand? • Do the rules contain technical language or jargon that is not clear? • Would a different format make the rules easier to understand; e.g., grouping and order of sections, use of headings, paragraphing? Regulatory Flexibility Act When will we start to use these rules? Anticipated Administrative Costs to the Social Security Administration We will not use these proposed rules until we evaluate public comments and publish final rules in the Federal Register. All final rules we issue include an effective date. We will continue to use our current rules until that date. If we publish final rules, we will include a summary of the relevant comments we received and an explanation of how we will apply the new rules. Regulatory Procedures jspears on DSK30JT082PROD with PROPOSAL10 We also determined that these proposed rules meet the plain language requirement of Executive Order 12866. We certify that these proposed rules would not have a significant economic impact on a substantial number of small entities because they affect individuals only. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended. Executive Order 13771 Anticipated Accounting Costs of These Proposed Rules Anticipated Costs to Our Programs Our Office of the Chief Actuary estimates, based on the best available data, that this proposed rule, assuming it is finalized and implemented for all disability decisions completed after February 1, 2020, would result in a reduction of $155 million in OASDI benefit payments and a reduction of $55 million in Federal SSI payments over the 10-year period of FY 2019–2028. The Office of Budget, Finance, and Management estimated administrative savings of less than 15 work years and $2 million annually, which we consider to be a non-significant amount. Paperwork Reduction Act These rules do not create any new or affect any existing collections and, therefore, do not require OMB approval under the Paperwork Reduction Act. References Executive Order 12866, as Supplemented by Executive Order 13563 We consulted the following references when we developed these proposed rules: We consulted with the Office of Management and Budget (OMB) and determined that these proposed rules meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB reviewed them. Digestive Disorders Annamalai, A., Harada, M., Chen, M., Tran, T., Ko, A., Ley, E., . . . Noureddin, M. (2016). Predictors of mortality in the critically ill cirrhotic patient: Is the model for end-stage liver disease enough? Journal of the American College of Surgeons, 224(3), 276–282. doi:10.1016/j.jamcollsurg.2016.11.005. VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 35943 Bajaj, J.S., O’Leary, J.G., Tandon, P., Wong, F., Garcia-Tsao, G., Kamath, P.S., . . . Reddy, K.R. (2017). Hepatic encephalopathy is associated with mortality in patients with cirrhosis independent of other extrahepatic organ failures. Clinical Gastroenterology and Hepatology, 15(4), 565–574. doi:10.1016/ j.cgh.2016.09.157. Bhutta, A.Q. & Garcia-Tsao, G. (2015). The role of medical therapy for variceal bleeding. Gastrointestinal Endoscopy Clinics of North America, 25(3), 479– 490. doi:10.1016/j.giec.2015.03.001. Brown, C.L., Hammill, B.G., Qualls, L.G., Curtis, L.H., & Muir, A.J. (2016). Significant morbidity and mortality among hospitalized end-stage liver disease patients in Medicare. Journal of Pain and Symptom Management, 52(3), 412–419. doi:10.1016/ j.jpainsymman.2016.03.013. Farraye, F.A., Melmed, G.Y., Lichtenstein, G.R., & Kane, S.V. (2017). ACG clinical guidelines: Preventative care in inflammatory bowel disease. American Journal of Gastroenterology, 112(2), 241– 258. Gajendran, M., Loganathan, P., Catinella, A.P., & Hashash, J.G. (2018). A comprehensive review and update on Crohn’s disease. Disease-a-Month, 64, 20–57. Garcia-Tsao, G. & Bosch, J. (2015). Varices and variceal hemorrhage in cirrhosis: A new view of an old problem. Clinical Gastroenterology and Hepatology, 13(12), 2109–2117. doi:10.1016/ j.cgh.2015.07.012. Jalan, R., Gines, P., Olson, J.C., Mookerjee, R.P., Moreau, R., Garcia-Tsao, G., . . . Kamath, P.S. (2012). Acute-on chronic liver failure. Journal of Hepatology, 57(6), 1336–1348. doi:10.1016/ j.jhep.2012.06.026. Kandiah, P.A. & Kumar, G. (2016). Hepatic encephalopathy—the old and the new. Critical Care Clinics, 32(3), 311–329. doi:10.1016/j.ccc.2016.03.001. Kim, K., Han, B.J., Yang, S., Na, S.Y., Park, S., Boo, S., . . . Kim, J. (2012). Risk factors and outcome of acute severe lower gastrointestinal bleeding in Crohn’s disease. Digestive and Liver Disease, 44(9), 723–728. doi:10.1016/ j.dld.2012.03.010. Lafferty, H.D., & Morris, J. (2015). Acute upper gastrointestinal haemorrhage. Medicine, 43(3), 161–166. doi:10.1016/ j.mpmed.2014.12.003. Macken, L. & Blaker, P.A. (2015). Management of acute severe ulcerative colitis (NICE CG 166). Clinical Medicine, 15(5), 473–476. doi.org/10.7861/ clinmedicine.15-5-473. Moore, K. (2015). Diagnosis and management of ascites and hepatorenal syndrome (acute kidney injury) in cirrhosis. Medicine, 43(11), 674–678. doi:10.1016/ j.mpmed.2015.08.004. Muir, A.J. (2015). Understanding the complexities of cirrhosis. Clinical Therapeutics, 37(8), 1822–1836. doi:10.1016/j.clinthera.2015.05.507. Naldi, M., Baldassarre, M., Domenicali, M., Bartolini, M., & Caraceni, P. (2017). E:\FR\FM\25JYP2.SGM 25JYP2 jspears on DSK30JT082PROD with PROPOSAL10 35944 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules Structural and functional integrity of human serum albumin: Analytical approaches and clinical relevance in patients with liver cirrhosis. Journal of Pharmaceutical and Biomedical Analysis, 144, 138–153. doi:10.1016/ j.jpba.2017.04.023. National Academies of Sciences, Engineering, and Medicine. (2018). Health-care utilization as a proxy in disability determination. Washington, DC: The National Academies Press. doi:10.17226/24969. Nevah, M.I. & Fallon, M. (2010). Hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, and systematic complications of liver disease. In M. Feldman, L.S. Friedman, & L.J. Brandt (Eds.), Sleisenger and Fordtran’s gastrointestinal and liver disease, (pp. 1543–1554). Philadelphia, PA: Saunders Elsevier. Nolan, J.D., Johnston, I.M., & Walters, J.R. (2015). Physiology of malabsorption. Surgery (Oxford), 55(5), 193–199. doi:10.1016/j.mpsur.2015.02.003. Peyrin-Biroulet, L., Pane´s, J., Sandborn, W.J., Vermeire, S., Danese, S., Feagan, B.G., . . . Rycroft, B. (2016). Defining disease severity in inflammatory bowel diseases: Current and future directions. Clinical Gastroenterology and Hepatology, 14(3), 348–354. doi:10.1016/j.cgh.2015.06.001. Rubin, D.T., Ananthakrishnan, A.N., Siegel, C.A., Sauer, B.G., & Long, M.D. (2019). ACG clinical guidelines: Ulcerative colitis in adults. American Journal of Gastroenterology, 114(3), 384–413. Shokoohi, H., Pourmand, A., Teng, J., & Lucas, J. (2017). Acute liver failure and emergency consideration for liver transplant. The American Journal of Emergency Medicine, 35(11), 1779–1781. doi:10.1016/j.ajem.2017.05.028. Singal, A.K. & Kamath, P.S. (2013). Model for end-stage liver disease. Journal of Clinical and Experimental Hepatology, 3(1), 50–60. doi:10.1016/ j.jceh.2012.11.002. Tee, C.T., Wallis, K., & Gabe, S.M. (2011). Emerging treatment options for short bowel syndrome: Potential role of teduglutide. Clinical and Experimental Gastroenterology, 4, 189–196. doi:10.2147/CEG.S13906. Vuachet, D., Cervoni, J., Vuitton, L., Weil, D., Dritsas, S., Dussaucy, A., . . . Thevenot, T. (2015). Improved survival of cirrhotic patients with variceal bleeding over the decade 2000–2010. Clinics and Research in Hepatology and Gastroenterology, 39(1), 59–67. doi:10.1016/ j.clinre.2014.06.018. Wei, Q., Nemdarry, R.S., Zhuang, R., Li, J., Ling, Q., Wu, J., . . . Zheng, S. (2017). A good prognostic predictor for liver transplantation recipients with benign end-stage liver cirrhosis. Hepatobiliary & Pancreatic Diseases International, 16(2), 164–168. doi:10.1016/S1499– 3872(16)60187–X. Yarur, A.J., Strobel, S.G., Deshpande, A.R., & Abreu, M.T. (2011). Predictors of aggressive inflammatory bowel disease. Gastroenterology & Hepatology, 7(10), 652–659. VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 Zhiang, E., Zhang, Z., Want, S., Xiao, Z., Gu, J., Xiong, M., . . . Huang, Z. (2016). Predicting the severity of liver cirrhosis through clinical parameters. Journal of Surgical Research, 204(2), 274–281. doi:10.1016/j.jss.2016.04.036. Skin Disorders De Jager, M.E., de Jong, E.M., van de Kerkhof, P.C., & Seyger M.M. (2010). Efficacy and safety of treatments for childhood psoriasis: A systematic literature review. Journal of the American Academy of Dermatology, 62(6), 1013–1030. doi:10.1016/j.jaad.2009.06.048. DiGiovanna, J.J., & Kraemer, K.H. (2012). Shining a light on xeroderma pigmentosum. Journal of Investigative Dermatology, 132(3), 785–796. doi:10.1038/jid.2011.426. Eichenfield, L.F., Tom, W.L., Berger, T.G., Krol, A., Paller, A.S., Schwarzenberger, K., . . . Sidbury, R. (2014). Guidelines of care for management of atopic dermatitis: Section 2. Management and treatment of atopic dermatitis with topical therapies. Journal of the American Academy of Dermatology, 71(1), 116–132. doi:10.1016/ j.jaad.2014.03.023. Farahnik, B., Nakamura, M., Singh, R.K., Abrouk, M., Zhu, T.H., Lee, K.M., . . . Liao, W. (2016). The patient’s guide to psoriasis treatment. Part 2: PUVA phototherapy. Dermatology and Therapy, 6(3), 315–324. doi:10.1007/ s13555–016–0130–9. Gupta, R., Woodley, D.T., & Chen, M. (2012). Epidermolysis bullosa acquisita. Clinics in Dermatology, 30(1), 60–69. doi:10.1016/j.clindermatol.2011.03.011. Jemec, G.B., & Kimball, A.B. (2015). Hidradenitis suppurativa: Epidemiology and scope of the problem. Journal of the American Academy of Dermatology, 73(5), S4–S7. doi:10.1016/ j.jaad.2015.07.052. Ong, S., & Venning, V. (2014). PUVA treatment information for patients. Retrieved from Oxford University Hospital NHS website: https:// www.ouh.nhs.uk/patient-guide/leaflets/ files/120719puva.pdf. Prens, E., & Deckers, I. (2015). Pathophysiology of hidradenitis suppurativa: An update. Journal of the American Academy of Dermatology, 73(5), S8–S11. doi:10.1016/ j.jaad.2015.07.045. Rachakonda, T.D., Schupp, C.W., & Armstrong, A.W. (2014). Psoriasis prevalence among adults in the United States. Journal of the American Academy of Dermatology, 70(3), 512–516. doi:10.1016/j.jaad.2013.11.013. Rich-Garg, N., Truong, B., Ehst, B., Deodhar, A., Ku, J., Vakil-Gilani, K., . . . Blauvelt, A. (2015). Demographics, clinical disease characteristics, and quality of life in a large cohort of psoriasis patients with and without psoriatic arthritis. Clinical, Cosmetic and Investigational Dermatology, 8, 563–569. doi:10.2147/ ccid.s90270. Schwieger-Briel, A., Moellmann, C., Mattulat, B., Schauer, F., Kiritsi, D., Schmidt, E., PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 . . . Kern, J.S. (2014). Bullous pemphigoid in infants: characteristics, diagnosis and treatment. Orphanet Journal of Rare Diseases, 9, 185. doi:10.1186/s13023–014–0185–6. Shenoi, S.D., & Prabhu, S. (2014). Photochemotherapy (PUVA) in psoriasis and vitiligo. Indian Journal of Dermatology, Venereology and Leprology, 80(6), 497–504. doi:10.4103/ 0378–6323.144143. Sidbury, R., Tom, W.L., Bergman, J.N., Cooper, K.D., Silverman, R.A., Berger, T.G., . . .Eichenfield, L.F. (2014). Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. Journal of the American Academy of Dermatology, 71(6), 1218–1233. doi:10.1016/ j.jaad.2014.08.038. Tollefson, M.M., Crowson, C.S., McEvoy, M.T., & Kremers, H.M. (2010). Incidence of psoriasis in children: A populationbased study. Journal of the American Academy of Dermatology, 62(6), 979– 987. doi:10.1016/j.jaad.2009.07.029. van der Zee, H.H., & Jemec, G.B. (2015). New insights into the diagnosis of hidradenitis suppurativa: Clinical presentations and phenotypes. Journal of the American Academy of Dermatology, 73(5), 23–26. doi:10.1016/ j.jaad.2015.07.047. Watson, W. & Kapur, S. (2011). Atopic dermatitis. Allergy, Asthma & Clinical Immunology, 7(1), 1–7. doi:10.1186/ 1710–1492–7–S1–S4. Weber, F., Schmuth, M., Seep, N., & Fritsch, P. (2005). Bath-water PUVA therapy with 8-methoxypsoralen in mycosis fungoides. Acta Dermato-Venereologica, 85, 329–332. doi:10.1080/ 00015550510032814. We will make these references available to you for inspection if you are interested in reading them. Please make arrangements with the contact person shown in this preamble if you would like to review any reference materials. (Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security— Disability Insurance; 96.002, Social Security—Retirement Insurance; 96.004, Social Security—Survivors Insurance; and 96.006, Supplemental Security Income). List of Subjects in 20 CFR Part 404 Administrative practice and procedure, Blind, Disability benefits, Old-age, survivors, and disability insurance, Reporting and recordkeeping requirements, Social Security. Andrew Saul, Commissioner of Social Security. For the reasons set forth in the preamble, we propose to amend subpart P of part 404 of title 20 of the Code of Federal Regulations as set forth below: E:\FR\FM\25JYP2.SGM 25JYP2 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950– ) Subpart P—Determining Disability and Blindness 1. The authority citation for subpart P of part 404 continues to read as follows: ■ Authority: Secs. 202, 205(a), (b), and (d)– (h), 216(i), 221(a) and (h)–(j), 222(c), 223, 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 405(a), (b), and (d)–(h), 416(i), 421(a) and (h)–(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 118 Stat. 509 (42 U.S.C. 902 note). 2. Amend appendix 1 to subpart P of part 404 as follows: ■ a. Revise items 6 and 9 of the introductory text before part A; ■ b. In part A, revise the body system name for section 5.00 in the table of contents and sections 5.00 and 8.00; and ■ c. In part B, revise the body system name for section 105.00 in the table of contents and sections 105.00 and 108.00. The revisions read as follows: ■ Appendix 1 to Subpart P of Part 404— Listing of Impairments * * * * * 6. Digestive Disorders (5.00 and 105.00) [date 5 years from the effective date of the final rule]. * * * * * 9. Skin Disorders (8.00 and 108.00) [date 5 years from the effective date of the final rule]. * * * * * * * * Part A jspears on DSK30JT082PROD with PROPOSAL10 * * 5.00 Digestive Disorders * * * * * 5.00 Digestive Disorders A. Which digestive disorders do we evaluate in this body system? We evaluate digestive disorders that result in severe dysfunction of the liver, pancreas, and gastrointestinal tract (the large, muscular tube that extends from the mouth to the anus, where the movement of muscles, along with the release of hormones and enzymes, allows for the digestion of food) in this body system. Examples of such disorders and the listings we use to evaluate them include chronic liver disease (5.05), inflammatory bowel disease (5.06), and short bowel syndrome (5.07). We also use this body system to evaluate gastrointestinal hemorrhaging from any cause (5.02), malnutrition due to any digestive disorder (5.08), liver transplantation (5.09), small intestine transplantation (5.11), and pancreas transplantation (5.12). We evaluate cancers affecting the digestive system under the listings in 13.00. B. What evidence do we need to evaluate your digestive disorder? 1. General. To establish that you have a digestive disorder, we need medical evidence VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 about the existence of your digestive disorder and its severity. Medical evidence should include your medical history, physical examination findings, operative reports, and relevant laboratory findings. 2. Laboratory findings. We need laboratory reports such as results of imaging (see 5.00B3), endoscopy, and other diagnostic procedures. We may also need clinical laboratory and pathology results. 3. Imaging refers to medical imaging techniques, such as x-ray, ultrasound, magnetic resonance imaging, and computerized tomography. The imaging must be consistent with the prevailing state of medical knowledge and clinical practice as a proper technique to support the evaluation of the disorder. C. What is chronic liver disease (CLD), and how do we evaluate it under 5.05? 1. General. CLD is loss of liver function with cell necrosis (cell death), inflammation, or scarring of the liver that persists for more than 6 months. Common causes of CLD in adults include chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), and prolonged alcohol abuse. a. We will evaluate your signs of CLD, such as jaundice, changes in size of the liver and spleen, ascites, peripheral edema, or altered mental status. We will also evaluate your symptoms of CLD, such as pruritus (itching), fatigue, nausea, loss of appetite, or sleep disturbances when we assess the severity of your impairment(s) and how it affects your ability to function. In the absence of evidence of a chronic liver impairment, episodes of acute liver disease do not meet the requirements of 5.05. b. Laboratory findings of your CLD may include decreased serum albumin, increased International Normalized Ratio (INR), arterial deoxygenation (hypoxemia), increased serum creatinine, oliguria (reduced urine output), or sodium retention. Another laboratory finding that may be included in the evidence is a liver biopsy. If you have had a liver biopsy, we will make every reasonable effort to obtain the results; however, we will not purchase a liver biopsy. 2. Manifestations of CLD. a. Gastrointestinal hemorrhaging (5.05A), as a consequence of cirrhosis and high pressure in the liver’s portal venous system, may occur from varices (dilated veins in the esophagus or the stomach) or from portal hypertensive gastropathy (abnormal mucosal changes in the stomach). When gastrointestinal hemorrhaging is due to a cause other than CLD, we evaluate it under 5.02. The phrase ‘‘consider under a disability for 1 year’’ in 5.02 and 5.05A does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. b. Ascites or hydrothorax (5.05B) is a pathologic accumulation of fluid in the peritoneal cavity (ascites) or pleural space (hydrothorax). Ascites or hydrothorax may be diagnosed by removing some of the fluid with needle aspiration (paracentesis or thoracentesis), physical examination, or imaging. The most common causes of ascites PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 35945 are portal hypertension and low serum albumin resulting from CLD. We evaluate other causes of ascites and hydrothorax that are unrelated to CLD, such as congestive heart failure and cancer, under the listings in the affected body systems. c. Spontaneous bacterial peritonitis (SBP) (5.05C) is an acute bacterial infection of peritoneal fluid, and is most commonly associated with CLD. SBP is diagnosed by laboratory analysis of peritoneal fluid (obtained by paracentesis) that contains a neutrophil count (also called absolute neutrophil count) of at least 250 cells/mm3. 5.05C is satisfied with one evaluation documenting peritoneal infection. We evaluate other causes of peritonitis that are unrelated to CLD, such as tuberculosis, malignancy, and perforated bowel, under the listings in the affected body systems. d. Hepatorenal syndrome (5.05D) is renal failure associated with CLD in the absence of underlying kidney pathology. Findings associated with hepatorenal syndrome include elevation of serum creatinine, sodium retention with low urinary sodium excretion, and oliguria (reduced output of urine). We evaluate renal dysfunction with known underlying kidney pathology, such as glomerulonephritis, tubular necrosis, and renal infections under the listings in 6.00. e. Hepatopulmonary syndrome (5.05E) is arterial deoxygenation (hypoxemia) due to intrapulmonary vascular dilation and arteriovenous shunting, associated with CLD. We evaluate pulmonary dysfunction with known underlying respiratory pathology, such as asthma, pneumonia, and pulmonary infections, under the listings in 3.00. (i) Under 5.05E1, we require a resting arterial blood gas (ABG) measurement obtained while you are breathing room air; that is, without oxygen supplementation. The ABG report must include the PaO2 value, your name, the date of the test, and either the altitude or both the city and State of the test site. (ii) We will not purchase the specialized imaging techniques described in 5.05E2; however, if you have had the test(s) at a time relevant to your claim, we will make every reasonable effort to obtain the report. f. Hepatic encephalopathy (5.05F), also known as portosystemic encephalopathy, is a recurrent or chronic neuropsychiatric disorder associated with CLD. (i) Under 5.05F2, we require documentation of a mental impairment associated with hepatic encephalopathy. A mental impairment can include abnormal behavior, changes in mental status, or an altered state of consciousness. Reports of abnormal behavior may show that you are experiencing delusions, paranoia, or hallucinations. Reports of changes in mental status may show change in sleep patterns, personality or mood changes, poor concentration, or poor judgment or cognitive dysfunction (for example, impaired memory, poor problem-solving ability, or attention deficits). Reports of altered state of consciousness may show that you are experiencing confusion, delirium, or stupor. (ii) Signs and laboratory findings that document the severity of hepatic encephalopathy when not attributable to E:\FR\FM\25JYP2.SGM 25JYP2 jspears on DSK30JT082PROD with PROPOSAL10 35946 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules other causes may include a ‘‘flapping tremor’’ (asterixis), characteristic abnormalities found on an electroencephalogram (EEG), or abnormal serum albumin or coagulation values. We will not purchase an EEG; however, if you have had this test at a time relevant to your claim, we will make every reasonable effort to obtain the report for the purpose of establishing whether your impairment meets the criteria of 5.05F. (iii) We will not evaluate acute encephalopathy under 5.05F if it results from conditions other than CLD. For example, we will evaluate acute encephalopathy caused by vascular events under the listings in 11.00 and acute encephalopathy caused by cancer under the listings in 13.00. 3. SSA CLD score (5.05G). Listing 5.05G requires two SSA CLD scores, each requiring three laboratory values. The ‘‘date of the SSA CLD score’’ is the date of the earliest of the three laboratory values used for its calculation. The date of the second SSA CLD score must be at least 60 days after the date of the first SSA CLD score and both scores must be within the required 12-month period. a. We calculate the SSA CLD score using a formula that includes three laboratory values: Serum creatinine (mg/dL), total bilirubin (mg/dL), and INR. The formula for the SSA CLD score calculation is: 9.57 × [loge(serum creatinine mg/dL)] + 3.78 × [loge(serum total bilirubin mg/dL)] + 11.2 × [loge(INR)] + 6.43 b. When we indicate ‘‘loge’’ (also abbreviated ‘‘ln’’) in the formula for the SSA CLD score calculation, we mean the ‘‘base e logarithm’’ or ‘‘natural logarithm’’ of the numerical laboratory value, not the ‘‘base 10 logarithm’’ or ‘‘common logarithm’’ (log) of the laboratory value, and not the actual laboratory value. For example, if a person has laboratory values of serum creatinine 2.0 mg/ dL, serum total bilirubin 1.5 mg/dL, and INR 1.0, we compute the SSA CLD score as follows: 9.57 × [loge(serum creatinine 2.0 mg/dL) = 0.693] + 3.78 × [loge(serum total bilirubin 1.5 mg/dL) = 0.405] + 11.2 × [loge(INR 1.0) = 0] + 6.43 = 6.63 + 1.53 + 0 + 6.43 = 14.6, which we round to an SSA CLD score of 15. c. For any SSA CLD score calculation, all of the required laboratory values (serum creatinine, serum total bilirubin, and INR) must have been obtained within a continuous 30-day period. We round any of the required laboratory values less than 1.0 up to 1.0 to calculate your SSA CLD score. If there are multiple laboratory values within the 30-day interval for any given laboratory test, we use the highest value to calculate your SSA CLD score. If you are in renal failure or on dialysis within a week of any serum creatinine test in the period used for the SSA CLD calculation, we will use a serum creatinine value of 4, which is the maximum serum creatinine level allowed in the calculation, to calculate your SSA CLD score. We will not use any INR values derived from testing done while you are on anticoagulant treatment in our SSA CLD calculation. We round the results of your SSA CLD score calculation to VerDate Sep<11>2014 17:34 Jul 24, 2019 Jkt 247001 the nearest whole integer to arrive at your SSA CLD score. D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 5.06? 1. IBD is a group of inflammatory conditions of the small intestine and colon. The most common IBD disorders are Crohn’s disease and ulcerative colitis. Remissions and exacerbations of variable duration are a hallmark of IBD. 2. We evaluate your signs and symptoms of IBD, such as diarrhea, fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever, nausea, vomiting, arthralgia, abdominal tenderness, and palpable abdominal mass (usually inflamed loops of bowel), when we assess the severity of your impairment(s). 3. We consider other signs or laboratory findings of IBD that indicate malnutrition, such as anemia, edema, weight loss, or hypoalbuminemia, when we determine your ability to maintain adequate nutrition. We evaluate your inability to maintain adequate nutrition under 5.08. 4. Repeated complications of IBD. a. Examples of complications of IBD include abscesses, intestinal perforation, toxic megacolon, infectious colitis, pyoderma gangrenosum, ureteral obstruction, primary sclerosing cholangitis, and hypercoagulable state (which may lead to thromboses or embolism). When we evaluate repeated complications of IBD, we consider all relevant information in your case record to determine the effects of your IBD on your ability to function independently, appropriately, effectively, and on a sustained basis. Factors we consider include, but are not limited to: Your symptoms, the frequency and duration of your complications, periods of exacerbation and remission, and the functional effects of your treatment, including the side effects of your medication. Your impairment will satisfy this criterion regardless of whether you have the same kind of complication repeatedly, all different complications, or any other combination of complications; for example, two of the same kind of complication and a different one. b. To satisfy the requirements described under 5.06C, your IBD must result in repeated complications and marked limitation in one of three areas of functioning: Activities of daily living; maintaining social functioning; or completing tasks in a timely manner due to deficiencies in concentration, persistence, or pace. If the complications do not last as long or occur as frequently as required under 5.06C, we will consider whether your IBD medically equals the listing. c. Marked limitation means that the signs and symptoms of your IBD interfere seriously with your ability to function. Although we do not require the use of such a scale, ‘‘marked’’ would be the fourth point on a five-point rating scale consisting of no limitation, mild limitation, moderate limitation, marked limitation, and extreme limitation. We do not define ‘‘marked’’ by a specific number of activities of daily living or different behaviors in which your social functioning is impaired, or a specific number of tasks that you are able to complete, but by the nature and overall degree of interference with your PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 functioning. You may have marked limitation when several activities or functions are impaired, or when only one is impaired. Additionally, you need not be totally precluded from performing an activity to have marked limitation, as long as the degree of limitation interferes seriously with your ability to function independently, appropriately, and effectively. The term ‘‘marked’’ does not imply that you must be confined to bed, hospitalized, or in a nursing home. d. Activities of daily living include, but are not limited to, such activities as doing household chores, grooming and hygiene, using a post office, taking public transportation, or paying bills. We will find that you have ‘‘marked’’ limitation in activities of daily living if you have a serious limitation in your ability to maintain a household or take public transportation because of symptoms, such as pain, severe fatigue, anxiety, or difficulty concentrating, caused by your IBD (including complications of the disorder) or its treatment, even if you are able to perform some self-care activities. e. Maintaining social functioning includes the capacity to interact independently, appropriately, effectively, and on a sustained basis with others. It includes the ability to communicate effectively with others. We will find that you have ‘‘marked’’ limitation in maintaining social functioning if you have a serious limitation in social interaction on a sustained basis because of symptoms, such as pain, severe fatigue, anxiety, or difficulty concentrating, or a pattern of exacerbation and remission, caused by your IBD (including complications of the disorder) or its treatment, even if you are able to communicate with close friends or relatives. f. Completing tasks in a timely manner due to deficiencies in concentration, persistence, or pace involves the ability to sustain concentration, persistence, or pace to permit timely completion of tasks commonly found in work settings. We will find that you have ‘‘marked’’ limitation in completing tasks if you have a serious limitation in your ability to sustain concentration or pace adequate to complete work-related tasks because of symptoms, such as pain, severe fatigue, anxiety, or difficulty concentrating, caused by your IBD (including complications of the disorder) or its treatment, even if you are able to do some routine activities of daily living. E. What is short bowel syndrome (SBS), and how do we evaluate it under 5.07? 1. SBS is a malabsorption disorder that occurs when ischemic vascular insults (caused, for example, by volvulus or necrotizing enterocolitis), trauma, or IBD complications require(s) surgical resection of any amount of the small intestine, resulting in chronic malnutrition. 2. We require a copy of the operative report that includes details of the surgical findings, or postoperative imaging indicating a resection of the small intestine. If we cannot get one of these reports, we need other medical reports that include details of the surgical findings. We also need medical documentation that you are dependent on daily parenteral nutrition to provide most of your nutritional requirements. F. How do we evaluate malnutrition due to any digestive disorder under 5.08? E:\FR\FM\25JYP2.SGM 25JYP2 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules 1. We evaluate malnutrition due to any digestive disorder using two body mass index (BMI) measurements at least 60 days apart in combination with an abnormal laboratory finding. If you have more than two BMI measurements within a consecutive 12month period, we will use your two lowest BMI measurements that are at least 60 days apart. 2. BMI is the ratio of your weight to the square of your height. a. We use measurements of your weight and height without shoes for these calculations. b. We calculate BMI using one of the following formulas: jspears on DSK30JT082PROD with PROPOSAL10 English Formula BMI = [Weight in Pounds/(Height in Inches × Height in Inches)] × 703 Metric Formulas BMI = Weight in Kilograms/(Height in Meters × Height in Meters) BMI = [Weight in Kilograms/(Height in Centimeters × Height in Centimeters)] × 10,000 G. How do we evaluate digestive organ transplantation? If you receive a liver (5.09), small intestine (5.11), or pancreas (5.12) transplant, we will consider you to be disabled under the listing for 1 year from the date of the transplant. After that, we evaluate your residual impairment(s) by considering the adequacy of your post-transplant function, the frequency and severity of any rejection episodes you have, complications in other body systems, and adverse treatment effects. People who receive digestive organ transplants generally have impairments that meet our definition of disability before they undergo transplantation. The phrase ‘‘consider under a disability for 1 year’’ in 5.09, 5.11, and 5.12 does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. H. How do we evaluate your digestive disorder if there is no record of ongoing treatment? If there is no record of ongoing treatment despite the existence of a severe impairment(s), we will assess the severity and duration of your digestive disorder based on the current medical and other evidence in your case record. If there is no record of ongoing treatment, you may not be able to show an impairment that meets a digestive disorders listing, but your impairment may medically equal a listing, or be disabling based on consideration of your residual functional capacity, age, education, and work experience. I. How do we evaluate your digestive disorder if there is evidence establishing a substance use disorder? If we find that you are disabled and there is medical evidence in your case record establishing that you have a substance use disorder, we will determine whether your substance use disorder is a contributing factor material to the determination of disability. See § 404.1535 and § 416.935 of this chapter. Digestive disorders resulting from drug or alcohol use VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 are often chronic in nature and will not necessarily improve with cessation in drug or alcohol use. J. How do we evaluate digestive disorders that do not meet one of these listings? 1. These listings are only examples of common digestive disorders that we consider severe enough to prevent you from doing any gainful activity. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that satisfies the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See § 404.1526 and § 416.926 of this chapter. Digestive disorders may be associated with disorders in other body systems, and we consider the combined effects of multiple impairments when we determine whether they medically equal a listing. If your impairment(s) does not meet or medically equal a listing, you may or may not have the residual functional capacity to engage in substantial gainful activity. We proceed to the fourth step and, if necessary, the fifth step of the sequential evaluation process in § 404.1520 and § 416.920 of this chapter. We use the rules in § 404.1594 and § 416.994 of this chapter, as appropriate, when we decide whether you continue to be disabled. 5.01 Category of Impairments, Digestive Disorders 5.02 Gastrointestinal hemorrhaging from any cause, requiring three blood transfusions of at least 2 units of blood per transfusion, within a consecutive 12-month period and at least 30 days apart. Consider under a disability for 1 year following the last documented transfusion; after that, evaluate the residual impairment(s). 5.03–5.04 [Reserved] 5.05 Chronic liver disease (CLD) (see 5.00C) with A, B, C, D, E, F, or G: A. Hemorrhaging from esophageal, gastric, or ectopic varices, or from portal hypertensive gastropathy (see 5.00C2a), documented by imaging (see 5.00B3); resulting in hemodynamic instability indicated by signs such as pallor (pale skin), diaphoresis (profuse perspiration), rapid pulse, low blood pressure, postural hypotension (pronounced fall in blood pressure when arising to an upright position from lying down, or syncope (fainting); and requiring hospitalization for transfusion of at least two units of blood. Consider under a disability for 1 year following the documented transfusion; after that, evaluate the residual impairment(s). OR B. Ascites or hydrothorax not attributable to other causes (see 5.00C2b), present on two evaluations within a consecutive 12-month period and at least 60 days apart. Each evaluation must document the ascites or hydrothorax by 1, 2, or 3: 1. Paracentesis; or 2. Thoracentesis; or 3. Imaging or physical examination with a or b: a. Serum albumin of 3.0 g/dL or less; or b. INR of at least 1.5. PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 35947 OR C. Spontaneous bacterial peritonitis (see 5.00C2c) documented by peritoneal fluid containing a neutrophil count of at least 250 cells/mm3. OR D. Hepatorenal syndrome (see 5.00C2d) documented by 1, 2, or 3: 1. Serum creatinine elevation of at least 2 mg/dL; or 2. Oliguria with 24-hour urine output less than 500 mL; or 3. Sodium retention with urine sodium less than 10 mEq per liter. OR E. Hepatopulmonary syndrome (see 5.00C2e) documented by 1 or 2: 1. Arterial PaO2 measured by an ABG test, while at rest, breathing room air, less than or equal to: a. 60 mm Hg, at test sites less than 3,000 feet above sea level; or b. 55 mm Hg, at test sites from 3,000 through 6,000 feet above sea level; or c. 50 mm Hg, at test sites over 6,000 feet above sea level; or 2. Intrapulmonary arteriovenous shunting as shown by contrast-enhanced echocardiography or macroaggregated albumin lung perfusion scan. OR F. Hepatic encephalopathy (see 5.00C2f) with documentation of abnormal behavior, cognitive dysfunction, changes in mental status, or altered state of consciousness (for example, confusion, delirium, stupor, or coma), present on two evaluations within a consecutive 12-month period and at least 60 days apart and either 1 or 2: 1. History of transjugular intrahepatic portosystemic shunt (TIPS) or other surgical portosystemic shunt; or 2. One of the following on at least two evaluations at least 60 days apart within the same consecutive 12-month period as in F: a. Asterixis or other fluctuating physical neurological abnormalities; or b. EEG demonstrating triphasic slow wave activity; or c. Serum albumin of 3.0 g/dL or less; or d. INR of 1.5 or greater. OR G. Two SSA CLD scores (see 5.00C3) of at least 20 within a consecutive 12-month period and at least 60 days apart. 5.06 Inflammatory bowel disease (IBD) (see 5.00D) documented by endoscopy, biopsy, imaging, or operative findings, and demonstrated by A, B, or C: A. Obstruction of stenotic areas (not adhesions) in the small intestine or colon with proximal dilatation, confirmed by imaging or in surgery, requiring two hospitalizations for intestinal decompression or for surgery, within a consecutive 12-month period and at least 60 days apart. OR B. Two of the following occurring within a consecutive 12-month period and at least 60 days apart: 1. Clinically documented tender abdominal mass palpable on physical examination with abdominal pain or cramping; or E:\FR\FM\25JYP2.SGM 25JYP2 35948 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules 2. Perineal disease with a draining abscess or fistula; or 3. Need for supplemental daily enteral nutrition via a gastrostomy or daily parenteral nutrition via a central venous catheter. OR C. Repeated complications of IBD (see 5.00D4a), occurring an average of three times a year, or once every 4 months, each lasting 2 weeks or more, within a consecutive 12month period, and marked limitation (see 5.00D4c) in one of the following: 1. Activities of daily living (see 5.00D4d); or 2. Maintaining social functioning (see 5.00D4e); or 3. Completing tasks in a timely manner due to deficiencies in concentration, persistence, or pace (see 5.00D4f). 5.07 Short bowel syndrome (SBS) (see 5.00E) due to surgical resection of any amount of the small intestine, resulting in dependence on daily parenteral nutrition via a central venous catheter. 5.08 Malnutrition due to any digestive disorder (see 5.00F), documented by A and B: A. One of the following: 1. Anemia with hemoglobin of less than 10.0 g/dL, present on two evaluations within a consecutive 12-month period and at least 60 days apart; or 2. Serum albumin of 3.0 g/dL or less, present on two evaluations within a consecutive 12-month period and at least 60 days apart. AND B. Two BMI measurements of less than 18.0 (see 5.00F2) within a consecutive 12month period and at least 60 days apart. 5.09 Liver transplantation (see 5.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). 5.10 [Reserved] 5.11 Small intestine transplantation (see 5.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). 5.12 Pancreas transplantation (see 5.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). jspears on DSK30JT082PROD with PROPOSAL10 * * * * * 8.00 Skin Disorders A. Which skin disorders do we evaluate under these listings? We use these listings to evaluate skin disorders that result from hereditary, congenital, or acquired pathological processes. We evaluate genetic photosensitivity disorders (8.07), burns (8.08), and chronic conditions of the skin or mucous membranes such as ichthyosis, bullous disease, dermatitis, psoriasis, and hidradenitis suppurativa (8.09). B. What are our definitions for the following terms used in this body system? 1. Assistive device(s): An assistive device, for the purposes of these listings, is any device used to improve stability, dexterity, or mobility. An assistive device can be handheld, such as a cane(s), a crutch(es), or a walker; or worn, such as a prosthesis or an orthosis. VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 2. Chronic skin lesions: Chronic skin lesions can have recurrent exacerbations. They can occur despite prescribed medical treatment. These chronic skin lesions can develop on any part of your body, including upper extremities, lower extremities, palms of your hands, soles of your feet, the perineum, inguinal (groin) region, and axillae (underarms). Chronic skin lesions may result in functional limitations as described in 8.00D2. 3. Contractures: Contractures are permanent fibrous scar tissue resulting in tightening and thickening of skin that prevents normal movement of the damaged area. They can develop on any part of your musculoskeletal system, including upper extremities, lower extremities, palms of your hands, soles of your feet, the perineum, inguinal (groin) region, and axillae (underarms). Contractures may result in functional limitations as described in 8.00D2. 4. Documented medical need: When we use the term ‘‘documented medical need,’’ we mean that there is evidence from your medical source(s) in the medical record that supports your need for an assistive device (see § 404.1513 and § 416.913 of this chapter). The evidence must include documentation from your medical source(s) describing any limitation(s) in your upper or lower extremity functioning that supports your need for the assistive device, and describing the circumstances for which you need it. The evidence does not have to include a specific prescription for the device. 5. Fine and gross movements: Fine movements, for the purposes of these listings, involve use of your wrists, hands, and fingers; such movements include picking, pinching, manipulating, and fingering. Gross movements involve use of your shoulders, upper arms, forearms, and hands; such movements include handling, gripping, grasping, holding, turning, and reaching. Gross movements also include exertional activities such as lifting, carrying, pushing, and pulling. 6. Surgical management: For the purposes of these listings, surgical management includes the surgery(-ies) itself, as well as various post-surgical procedures, surgical complications, infections or other medical complications, related illnesses, or related treatments that delay a person’s attainment of maximum benefit from surgery. C. What evidence do we need to evaluate your skin disorder? 1. To establish the presence of a skin disorder as a medically determinable impairment, we need objective medical evidence from an acceptable medical source who has examined you for the disorder. 2. We will make every reasonable effort to obtain your medical history, treatment records, and relevant laboratory findings, but we will not purchase genetic testing. 3. When we evaluate the presence and severity of your skin disorder(s), we generally need information regarding: a. The onset, duration, and frequency of exacerbations; b. The prognosis of your skin disorder; c. The location, size, and appearance of lesions and contractures; PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 d. Your history of familial incidence; exposure to toxins, allergens or irritants; seasonal variations; and stress factors; e. Your ability to function outside of a highly protective environment; f. Laboratory findings (for example, a biopsy obtained independently of Social Security disability evaluation or results of blood tests); g. Evidence from other medically acceptable methods consistent with the prevailing state of medical knowledge and clinical practice; and h. Statements you or others make about your disorder(s), your restrictions, and your daily activities. D. How do we evaluate the severity of skin disorders? 1. General. We evaluate the severity of skin disorders based on the site(s) of your chronic skin lesions or contractures, functional limitations caused by your signs and symptoms (including pain) (see 8.00D2), and how your prescribed treatment affects you. We consider the frequency and severity of your exacerbations, how quickly they resolve, and how you function between exacerbations, to determine whether your skin disorder meets or medically equals a listing. If there is no record of ongoing medical treatment for your disorder, we will follow the guidelines in 8.00D6. We will determine the extent and kinds of evidence we need from medical and non-medical sources based on the individual facts about your disorder. For our basic rules on evidence, see §§ 404.1512, 404.1513, and 404.1520b and §§ 416.912, 416.913, and 416.920b of this chapter. For our rules on evaluating your symptoms, see § 404.1529 and § 416.929 of this chapter. 2. Limitation(s) of physical functioning due to skin disorders. a. Skin disorders may be due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3), and may cause pain or restrict movement, which can limit your ability to initiate, sustain, and complete work-related activities. For example, skin lesions in the axilla may limit your ability to raise or reach with the affected arm, or lesions in the inguinal region may limit your ability to ambulate, sit, or lift and carry. To evaluate your skin disorder(s) under 8.07B, 8.08, and 8.09, we require medically documented evidence of physical limitation(s) of functioning related to your disorder. The decrease in physical function must have lasted, or can be expected to last, for a continuous period of at least 12 months (see § 404.1509 and § 416.909 of this chapter). Xeroderma pigmentosum is the only skin disorder that does not include functional criteria because the characteristics and severity of the disorder itself are sufficient to meet the criteria in 8.07A. b. The functional criteria require impairment-related physical limitations in using upper or lower extremities that have lasted, or can be expected to last, for a continuous period of at least 12 months, medically documented by one of the following: (i) Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete E:\FR\FM\25JYP2.SGM 25JYP2 jspears on DSK30JT082PROD with PROPOSAL10 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules work-related activities involving fine and gross movements; (ii) Inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements due to chronic skin lesions or contractures, and a documented medical need for a one-handed assistive device that requires the use of your other upper extremity; or (iii) Inability to stand up from a seated position and maintain an upright position to the extent you can independently initiate, sustain, and complete work-related activities due to chronic skin lesions or contractures affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or (iv) Inability to maintain an upright position while standing or walking, to independently initiate, sustain, and complete work-related activities due to chronic skin lesions or contractures affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 3. Frequency of exacerbations due to chronic skin lesions. A skin disorder resulting in chronic skin lesions (see 8.00B2) may have frequent exacerbations severe enough to meet a listing even if each individual skin lesion exacerbation did not last for an extended amount of time. We will consider the frequency, severity, and duration of skin lesion exacerbations; how quickly they resolve; and how you function in the time between skin lesion exacerbations, to determine whether your skin disorder meets or equals a listing. 4. Symptoms (including pain). Your symptoms may be an important factor in our determination of whether your skin disorder(s) meets or medically equals a listing, or whether you are otherwise able to work. We consider your symptoms only when you have a medically determinable impairment that could reasonably be expected to produce the symptoms. See § 404.1529 and § 416.929 of this chapter. 5. Treatment. a. General. Treatments for skin disorders may have beneficial or adverse effects, and responses to treatment vary from person to person. Your skin disorder’s response to treatment may vary due to treatment resistance or side effects that can result in functional limitations. We will evaluate all of the effects of treatment (including surgical treatment, medications, and therapy) on the symptoms, signs, and laboratory findings of your skin disorder, and on your ability to function. b. Despite adherence to prescribed medical treatment for 3 months. Under 8.09, we require that your symptoms persist ‘‘despite adherence to prescribed medical treatment for 3 months.’’ This requirement means that you must have taken prescribed medication(s) or followed other medical treatment prescribed by a physician for 3 consecutive months. Treatment or effects of treatment may be temporary. In most cases, sufficient time must elapse to allow us to evaluate your response to treatment, including any side effects. For our purposes, ‘‘sufficient time’’ means a period of at least VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 3 months. If your treatment has not lasted for at least 3 months, we will follow the rules in 8.00D6a. To evaluate the severity of physical limitations due to your skin disorder(s), we require medically documented evidence of disorder-related physical limitation(s) of functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months. See § 404.1509 and § 416.909 of this chapter. The 3 months adherence to prescribed medical treatment must be within the period of at least 12 months that we use to evaluate severity. c. Treatment with PUVA (psoralen and ultraviolet A (UVA) light) or biologics. If you receive additional treatment with PUVA or biologics to treat your skin disorder(s), we will defer adjudication of your claim for 6 months from the start of treatment with PUVA or biologics to evaluate the effectiveness of these treatments unless we can make a fully favorable determination or decision on another basis. 6. No record of ongoing treatment. a. Despite having a skin disorder, you may not have received ongoing treatment, may have just begun treatment, may not have access to prescribed medical treatment, or may not have an ongoing relationship with the medical community. In any of these situations, you will not have a longitudinal medical record for us to review when we evaluate your disorder. In some instances, we may be able to assess the severity and duration of your skin disorder based on your medical record and current evidence alone. We may ask you to attend a consultative examination to determine the severity and potential duration of your skin disorder (see § 404.1519a and § 416.919a of this chapter). b. If, for any reason, you have not received treatment, your skin disorder cannot meet the criteria for 8.09. If the information in your case record is not sufficient to show that you have a skin disorder that meets the criteria of one of the skin disorders listings, we will follow the rules in 8.00I. E. How do we evaluate genetic photosensitivity disorders under 8.07? Genetic photosensitivity disorders are disorders of the skin caused by an increase in the sensitivity of the skin to sources of ultraviolet light, including sunlight. 1. Xeroderma pigmentosum (XP) (8.07A). XP is a genetic photosensitivity disorder with lifelong hypersensitivity to all forms of ultraviolet light. Laboratory testing confirms the diagnosis by documenting abnormalities in the body’s ability to repair DNA (deoxyribonucleic acid) mutations after ultraviolet light exposure. Your skin disorder meets the requirements of 8.07A if you have clinical and laboratory findings supporting a diagnosis of XP (see 8.00E3). 2. Other genetic photosensitivity disorders (8.07B). The effects of other genetic photosensitivity disorders may vary and may not persist over time. To meet the requirements of 8.07B, a genetic photosensitivity disorder other than XP must be established by clinical and laboratory findings (see 8.00C) and must result either in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) that result in functional limitations (see 8.00D), or must PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 35949 result in the inability to function outside of a highly protective environment. Some genetic photosensitivity disorders can have very serious effects on other body systems, especially special senses and speech, neurological, mental, and cancer. We will evaluate your disorder(s) under the listings in 2.00, 11.00, 12.00, or 13.00, as appropriate. 3. What evidence do we need to document that you have XP or another genetic photosensitivity disorder? We will make a reasonable effort to obtain evidence of your disorder(s), but we will not purchase genetic testing. When the results of genetic tests are part of the existing evidence in your case record, we will evaluate the test results with all other relevant evidence. We need the following clinical and laboratory findings to document that you have XP or another genetic photosensitivity disorder: a. A laboratory report of a definitive genetic laboratory test documenting appropriate chromosomal changes, including abnormal DNA repair or another DNA abnormality specific to your type of photosensitivity disorder, signed by an acceptable medical source (AMS); or b. A laboratory report of a definitive test that is not signed by an AMS, and a report from an AMS stating that you have undergone definitive genetic laboratory studies documenting appropriate chromosomal changes, including abnormal DNA repair or another DNA abnormality specific to your type of photosensitivity disorder; or c. If we do not have a laboratory report of a definitive test, we need documentation from an AMS that an appropriate laboratory analysis or other diagnostic method(s) confirms a positive diagnosis of your skin disorder. This documentation must state that you had the appropriate definitive laboratory test(s) for diagnosing your disorder and provide the results, or explain how another diagnostic method(s), consistent with the prevailing state of medical knowledge and clinical practice, established your diagnosis. 4. Inability to function outside of a highly protective environment means that you must avoid exposure to ultraviolet light (including sunlight passing through windows and light from similar unshielded light sources), wear protective clothing and eyeglasses, and use opaque broad-spectrum sunscreens in order to avoid skin cancer or other serious effects. F. How do we evaluate burns under 8.08? 1. Electrical, chemical, or thermal burns frequently affect other body systems, for example, musculoskeletal, special senses and speech, respiratory, cardiovascular, genitourinary, neurological, or mental. We evaluate burns in the same way we evaluate other disorders that can affect the skin and other body systems, using the listing for the predominant feature of your disorder. For example, if your soft tissue injuries resulting from burns are under surgical management (as defined in 8.00B6), we will evaluate your disorder under the listings in 1.00. 2. We evaluate third-degree burns resulting in contractures (see 8.00B3) that have been documented by an acceptable medical source to have reached maximum therapeutic benefit and therefore are no longer receiving surgical management, under 8.08. To be E:\FR\FM\25JYP2.SGM 25JYP2 jspears on DSK30JT082PROD with PROPOSAL10 35950 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules disabling, these burns must result in functional limitation(s) (see 8.00D2) that has lasted or can be expected to last for a continuous period of at least 12 months. G. How do we evaluate chronic conditions of the skin or mucous membranes under 8.09? We evaluate skin disorders that result in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) under 8.09. These disorders must result in chronic skin lesions or contractures that continue to persist despite adherence to prescribed medical treatment for 3 months (see 8.00D5b) and cause functional limitations (see 8.00D2). Examples of skin disorders evaluated under this listing are ichthyosis, bullous diseases (such as pemphigus, epidermolysis bullosa, and dermatitis herpetiformis), chronic skin infections, dermatitis, psoriasis, and hidradenitis suppurativa. H. How do we evaluate disorders in other body systems that affect the skin? When your disorder(s) in another body system affects the skin, we first evaluate the predominant feature of your disorder(s) under the appropriate body system. Examples of disorders in other body systems that may affect the skin include the following: 1. Diabetes mellitus. Diabetes mellitus that is not well controlled, despite treatment, can cause chronic hyperglycemia resulting in serious, long-lasting or recurrent exacerbations or complications. We evaluate those exacerbations or complications under the affected body system(s). If the complication involves soft tissue or amputation(s), we evaluate these features under the listings in 1.00. If the exacerbations or complications involve chronic bacterial or fungal skin lesions resulting from diabetes mellitus, we evaluate your limitations from the skin disorder under listing 8.09. 2. Tuberous sclerosis. The predominant functionally limiting features of tuberous sclerosis are seizures and intellectual disability or other mental disorders. We evaluate these features under the listings in 11.00 or 12.00, as appropriate. 3. Malignant tumors of the skin. Malignant tumors of the skin (for example, malignant melanomas) are cancers, or malignant neoplastic diseases, that we evaluate under the listings in 13.00. 4. Immune system disorders. We evaluate skin manifestations of immune system disorders such as systemic lupus erythematosus, scleroderma, psoriasis, and human immunodeficiency virus (HIV) infection under the listings in 14.00. 5. Head or facial disfigurement or deformity, and other physical deformities caused by skin disorders. A head or facial disfigurement or deformity may result in loss of your sight, hearing, speech, or ability to chew. In addition to head and facial disfigurement and deformity, other physical deformities may result in associated psychological problems (for example, depression). We evaluate the effects of head or facial disfigurement or deformity, or other physical deformities caused by skin disorders under the listings in 1.00, 2.00, 5.00, or 12.00, as appropriate. I. How do we evaluate skin disorders that do not meet one of these listings? 1. These listings are only examples of common skin disorders that we consider VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 severe enough to prevent you from doing any gainful activity. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that satisfies the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See § 404.1526 and § 416.926 of this chapter. If your impairment(s) does not meet or medically equal a listing, you may or may not have the residual functional capacity to engage in substantial gainful activity. We proceed to the fourth step and, if necessary, the fifth step of the sequential evaluation process in § 404.1520 and § 416.920 of this chapter. We use the rules in § 404.1594 and § 416.994 of this chapter, as appropriate, when we decide whether you continue to be disabled. 8.01 Category of Impairments, Skin Disorders 8.02–8.06 [Reserved] 8.07 Genetic photosensitivity disorders, established as described in 8.00E. The requirements of this listing are met if either paragraph A or paragraph B is satisfied. A. Xeroderma pigmentosum (see 8.00E1). OR B. Other genetic photosensitivity disorders (see 8.00E2) with either 1 or 2: 1. Chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) that cause an inability to function outside of a highly protective environment (see 8.00E4); or 2. Chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) that cause functional limitations (see 8.00D2) due to limitation(s) from your skin condition, such as pain, as evidenced by: a. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements; or b. Inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (due to chronic skin lesions or contractures), and a documented medical need for a one-handed assistive device that requires the use of your other upper extremity; or c. Inability to stand up from a seated position and maintain an upright position to the extent you can independently initiate, sustain, and complete work-related activities due to chronic skin lesions or contractures affecting at least two extremities (including when limitations are due to involvement of the perineum or the inguinal region); or d. Inability to maintain an upright position while standing or walking, to independently initiate, sustain, and complete work-related activities due to chronic skin lesions or contractures affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 8.08 Burns (see 8.00F). Third-degree burns that do not require continuing surgical management, or that have been documented by an acceptable medical source to have reached maximum therapeutic benefit and PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 therefore are no longer receiving surgical management, resulting in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) that cause functional limitations (see 8.00D2) due to limitation(s), such as pain, from your skin condition, as evidenced by: A. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements. OR B. Inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (due to chronic skin lesions or contractures), and a documented medical need for a one-handed assistive device that requires the use of your other upper extremity. OR C. Inability to stand up from a seated position and maintain an upright position to the extent you can independently initiate, sustain, and complete work-related activities due to chronic skin lesions or contractures affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region). OR D. Inability to maintain an upright position while standing or walking, to independently initiate, sustain, and complete work-related activities due to chronic skin lesions or contractures affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 8.09 Chronic conditions of the skin or mucous membranes (see 8.00G) resulting in: A. Chronic skin lesions (see 8.00B2) or contractures (see 8.00B3); chronic pain; or other physical limitation(s); that persist despite adherence to prescribed medical treatment for 3 months (see 8.00D5b), causing functional limitations (see 8.00D2) due to limitation(s), such as pain, from your skin condition. AND B. Impairment-related significant limitation demonstrated by 1, 2, 3, or 4: 1. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements; or 2. Inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (due to chronic skin lesions or contractures), and a documented medical need for a one-handed assistive device that requires the use of your other upper extremity; or 3. Inability to stand up from a seated position and maintain an upright position to the extent you can independently initiate, sustain, and complete work-related activities due to chronic skin lesions or contractures affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or 4. Inability to maintain an upright position while standing or walking, to independently E:\FR\FM\25JYP2.SGM 25JYP2 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules initiate, sustain, and complete work-related activities due to chronic skin lesions or contractures affecting both lower extremities (including when the limitations are due to the involvement of the perineum or the inguinal region). * * * * * * * * Part B * * 105.00 jspears on DSK30JT082PROD with PROPOSAL10 * * Digestive Disorders * * * 105.00 Digestive Disorders A. Which digestive disorders do we evaluate in this body system? We evaluate digestive disorders that result in severe dysfunction of the liver, pancreas, and gastrointestinal tract (the large, muscular tube that extends from the mouth to the anus, where the movement of muscles, along with the release of hormones and enzymes, allows for the digestion of food) in this body system. Examples of such disorders and the listings we use to evaluate them include chronic liver disease (105.05), inflammatory bowel disease (105.06), and short bowel syndrome (105.07). We also use this body system to evaluate gastrointestinal hemorrhaging from any cause (105.02), growth failure due to any digestive disorder (105.08), liver transplantation (105.09), need for supplemental daily enteral feeding via a gastrostomy due to any cause for children who have not attained age 3 (105.10), small intestine transplantation (105.11), and pancreas transplantation (105.12). We evaluate cancers affecting the digestive system under the listings in 113.00. B. What evidence do we need to evaluate your digestive disorder? 1. General. To establish that you have a digestive disorder, we need medical evidence about the existence of your digestive disorder and its severity. Medical evidence should include your medical history, physical examination findings, operative reports, and relevant laboratory findings. 2. Laboratory findings. We need laboratory reports such as results of imaging (see 105.00B3), endoscopy, and other diagnostic procedures. We may also need clinical laboratory and pathology results. 3. Imaging refers to medical imaging techniques, such as x-ray, ultrasound, magnetic resonance imaging, and computerized tomography. The imaging must be consistent with the prevailing state of medical knowledge and clinical practice as a proper technique to support the evaluation of the disorder. C. What is chronic liver disease (CLD), and how do we evaluate it under 105.05? 1. General. CLD is loss of liver function with cell necrosis (cell death), inflammation, or scarring of the liver that persists for more than 6 months. Common causes of CLD in children include chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), autoimmune hepatitis, and metabolic disease. a. We will evaluate your signs of CLD, such as jaundice, changes in size of the liver and spleen, ascites, peripheral edema, or altered mental status. We will also evaluate your symptoms of CLD, such as pruritus (itching), VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 fatigue, nausea, loss of appetite, or sleep disturbances when we assess the severity of your impairment(s) and how it affects your ability to function. In the absence of evidence of a chronic liver impairment, episodes of acute liver disease do not meet the requirements of 105.05. b. Laboratory findings of your CLD may include decreased serum albumin, increased International Normalized Ratio (INR), arterial deoxygenation (hypoxemia), increased serum creatinine, oliguria (reduced urine output), or sodium retention. Another laboratory finding that may be included in the evidence is a liver biopsy. If you have had a liver biopsy, we will make every reasonable effort to obtain the results; however, we will not purchase a liver biopsy. 2. Manifestations of CLD. a. Gastrointestinal hemorrhaging (105.05A), as a consequence of cirrhosis and high pressure in the liver’s portal venous system, may occur from varices (dilated veins in the esophagus or the stomach) or from portal hypertensive gastropathy (abnormal mucosal changes in the stomach). When gastrointestinal hemorrhaging is due to a cause other than CLD, we evaluate it under 105.02. The phrase ‘‘consider under a disability for 1 year’’ in 105.02 and 105.05A does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. b. Ascites or hydrothorax (105.05B) is a pathologic accumulation of fluid in the peritoneal cavity (ascites) or pleural space (hydrothorax). Ascites or hydrothorax may be diagnosed by removing some of the fluid with needle aspiration (paracentesis or thoracentesis), physical examination, or imaging. The most common causes of ascites are portal hypertension and low serum albumin resulting from CLD. We evaluate other causes of ascites and hydrothorax that are unrelated to CLD, such as congestive heart failure and cancer, under the listings in the affected body systems. c. Spontaneous bacterial peritonitis (SBP) (105.05C) is an acute bacterial infection of peritoneal fluid, and is most commonly associated with CLD. SBP is diagnosed by laboratory analysis of peritoneal fluid (obtained by paracentesis) that contains a neutrophil count (also called absolute neutrophil count) of at least 250 cells/mm3. 105.05C is satisfied with one evaluation documenting peritoneal infection. We evaluate other causes of peritonitis that are unrelated to CLD, such as tuberculosis, malignancy, and perforated bowel, under the listings in the affected body systems. d. Hepatorenal syndrome (105.05D) is renal failure associated with CLD in the absence of underlying kidney pathology. Findings associated with hepatorenal syndrome include elevation of serum creatinine, sodium retention with low urinary sodium excretion, and oliguria (reduced output of urine). We evaluate renal dysfunction with known underlying kidney pathology, such as glomerulonephritis, tubular necrosis, and renal infections under the listings in 106.00. PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 35951 e. Hepatopulmonary syndrome (105.05E) is arterial deoxygenation (hypoxemia) due to intrapulmonary vascular dilation and arteriovenous shunting, associated with CLD. We evaluate pulmonary dysfunction with known underlying respiratory pathology, such as asthma, pneumonia, and pulmonary infections, under the listings in 103.00. (i) Under 105.05E1, we require a resting arterial blood gas (ABG) measurement obtained while you are breathing room air; that is, without oxygen supplementation. The ABG report must include the PaO2 value, your name, the date of the test, and either the altitude or both the city and State of the test site. (ii) We will not purchase the specialized imaging techniques described in 105.05E2; however, if you have had the test(s) at a time relevant to your claim, we will make every reasonable effort to obtain the report. f. Hepatic encephalopathy (105.05F), also known as portosystemic encephalopathy, is a recurrent or chronic neuropsychiatric disorder associated with CLD. (i) Under 105.05F2, we require documentation of a mental impairment associated with hepatic encephalopathy. A mental impairment can include abnormal behavior, changes in mental status, or an altered state of consciousness. Reports of abnormal behavior may show that you are experiencing delusions, paranoia, or hallucinations. Reports of changes in mental status may show change in sleep patterns, personality or mood changes, poor concentration, or poor judgment or cognitive dysfunction (for example, impaired memory, poor problem-solving ability, or attention deficits). Reports of altered state of consciousness may show that you are experiencing confusion, delirium, or stupor. (ii) Signs and laboratory findings that document the severity of hepatic encephalopathy when not attributable to other causes may include a ‘‘flapping tremor’’ (asterixis), characteristic abnormalities found on an electroencephalogram (EEG), or abnormal serum albumin or coagulation values. We will not purchase an EEG; however, if you have had this test at a time relevant to your claim, we will make every reasonable effort to obtain the report for the purpose of establishing whether your impairment meets the criteria of 105.05F. (iii) We will not evaluate acute encephalopathy under 105.05F if it results from conditions other than CLD. For example, we will evaluate acute encephalopathy caused by vascular events under the listings in 111.00 and acute encephalopathy caused by cancer under the listings in 113.00. 3. SSA CLD and SSA CLD–P scores (105.05G). Listing 105.05G1 requires two SSA CLD scores, each requiring three laboratory values, or two SSA CLD–P scores, each requiring four parameters (three laboratory values and growth failure). The ‘‘date of the SSA CLD score’’ is the date of the earliest of the three laboratory values used for its calculation. The ‘‘date of the SSA CLD–P score’’ is the date of the earliest of the three laboratory values used for its calculation. For 105.05G1, the date of the second SSA CLD or SSA CLD–P score must E:\FR\FM\25JYP2.SGM 25JYP2 jspears on DSK30JT082PROD with PROPOSAL10 35952 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules be at least 60 days after the date of the first SSA CLD or SSA CLD–P score and both scores must be within the required 12-month period. Listing 105.05G2 requires one SSA CLD–P score. a. SSA CLD score. (i) We calculate the SSA CLD score using a formula that includes three laboratory values: Serum creatinine (mg/dL), total bilirubin (mg/dL), and INR. The formula for the SSA CLD score calculation is: 9.57 × [loge(serum creatinine mg/dL)] + 3.78 × [loge(serum total bilirubin mg/dL)] + 11.2 × [loge(INR)] + 6.43 (ii) When we indicate ‘‘loge’’ (also abbreviated ‘‘ln’’) in the formula for the SSA CLD score calculation, we mean the ‘‘base e logarithm’’ or ‘‘natural logarithm’’ of the numerical laboratory value, not the ‘‘base 10 logarithm’’ or ‘‘common logarithm’’ (log) of the laboratory value, and not the actual laboratory value. For example, if a person has laboratory values of serum creatinine 2.0 mg/ dL, serum total bilirubin 1.5 mg/dL, and INR 1.0, we compute the SSA CLD score as follows: 9.57 × [loge(serum creatinine 2.0 mg/dL) = 0.693] + 3.78 × [loge(serum total bilirubin 1.5 mg/dL) = 0.405] + 11.2 × [loge(INR 1.0) = 0] + 6.43 = 6.63 + 1.53 + 0 + 6.43 = 14.6, which we round to an SSA CLD score of 15. (iii) For an SSA CLD score calculation, all of the required laboratory values (serum creatinine, serum total bilirubin, and INR) must have been obtained within a continuous 30-day period. We round any of the required laboratory values less than 1.0 up to 1.0 to calculate your SSA CLD score. If there are multiple laboratory values within the 30-day interval for any given laboratory test, we use the highest value to calculate your SSA CLD score. If you are in renal failure or on dialysis within a week of any serum creatinine test in the period used for the SSA CLD calculation, we will use a serum creatinine value of 4, which is the maximum serum creatinine level allowed in the calculation, to calculate your SSA CLD score. We will not use any INR values derived from testing done while you are on anticoagulant treatment in our SSA CLD calculation. We round the results of your SSA CLD score calculation to the nearest whole integer to arrive at your SSA CLD score. b. SSA CLD–P score (i) We calculate the SSA CLD–P scores using a formula that includes four parameters: Serum total bilirubin (mg/dL), INR, serum albumin (g/dL), and whether you have growth failure. The formula for the SSA CLD–P score calculation is: 4.80 × [loge(serum total bilirubin mg/dL)] + 18.57 × [loge(INR)] ¥ 6.87 × [loge(serum albumin g/dL)] + 6.67 if you have growth failure (<¥2 standard deviations for weight or height) (ii) When we indicate ‘‘loge’’ in the formula for the SSA CLD–P score calculation, we mean the ‘‘base e logarithm’’ or ‘‘natural logarithm’’ (loge) of a numerical laboratory value, not the ‘‘base 10 logarithm’’ or ‘‘common logarithm’’ (log) of the laboratory value, and not the actual laboratory value. VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 For example, if a female child is 4.0 years old, has growth failure, and has laboratory values of serum total bilirubin 2.2 mg/dL, INR 1.0, and serum albumin 3.5 g/dL, we compute the SSA CLD–P score as follows: 4.80 × [loge(serum total bilirubin 2.2 mg/dL) = 0.788] + 18.57 × [loge(INR 1.0) = 0] ¥ 6.87 × [loge(serum albumin 3.5 g/dL) = 1.253] + 6.67 = 3.78 + 0 ¥ 8.61 + 6.67 = 1.84, which we round to an SSA CLD–P score of 2. (iii) For an SSA CLD–P score calculation, all of the required laboratory values (serum total bilirubin, INR, and serum albumin) must have been obtained within a continuous 30-day period. We round any of the required laboratory values less than 1.0 up to 1.0 to calculate your SSA CLD–P score. If there are multiple laboratory values within the 30-day interval for any given laboratory test, we use the highest serum total bilirubin and INR values and the lowest serum albumin value to calculate the SSA CLD–P score. We will not use any INR values derived from testing done while you are on anticoagulant treatment in our SSA CLD–P calculation. We will not purchase INR values for children who have not attained age 12. If there is no INR value for a child under 12 within the applicable period, we will use an INR value of 1.1 to calculate the SSA CLD–P score. We round the results of your SSA CLD–P score calculation to the nearest whole integer to arrive at your SSA CLD–P score. (iv) The weight and length/height measurements used for the calculation must be obtained within the same 30-day period as the laboratory values. 4. Extrahepatic biliary atresia (105.05H) presents itself in the first 2 months of life with persistent jaundice. To satisfy 105.05H, the diagnosis of extrahepatic biliary atresia must be confirmed by liver biopsy or intraoperative cholangiogram that shows obliteration of the extrahepatic biliary tree. Biliary atresia is usually treated surgically by portoenterostomy (for example, Kasai procedure). If this surgery is not performed in the first months of life or is not completely successful, liver transplantation is indicated. If you have received a liver transplant, we will evaluate your impairment under 105.09. The phrase ‘‘consider under a disability for 1 year’’ in 105.05H does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 105.06? 1. IBD is a group of inflammatory conditions of the small intestine and colon. The most common IBD disorders are Crohn’s disease and ulcerative colitis. Remissions and exacerbations of variable duration are a hallmark of IBD. 2. We evaluate your signs and symptoms of IBD, such as diarrhea, fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever, nausea, vomiting, arthralgia, abdominal tenderness, and palpable abdominal mass (usually inflamed loops of PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 bowel), when we assess the severity of your impairment(s). 3. We consider other signs or laboratory findings of IBD that indicate malnutrition, such as anemia, edema, weight loss, or hypoalbuminemia, when we determine your ability to maintain adequate nutrition. We evaluate your inability to maintain adequate nutrition under 105.08. 4. Examples of complications of IBD that may result in hospitalization include abscesses, intestinal perforation, toxic megacolon, infectious colitis, pyoderma gangrenosum, ureteral obstruction, primary sclerosing cholangitis, and hypercoagulable state (which may lead to thromboses or embolism). The three hospitalizations in 105.06C do not have to be for the same complication of IBD. E. What is short bowel syndrome (SBS), and how do we evaluate it under 105.07? 1. SBS is a malabsorption disorder that occurs when congenital intestinal abnormalities, ischemic vascular insults (caused, for example, by volvulus or necrotizing enterocolitis), trauma, or IBD complications require(s) surgical resection of any amount of the small intestine, resulting in chronic malnutrition. 2. We require a copy of the operative report that includes details of the surgical findings, or postoperative imaging indicating a resection of the small intestine. If we cannot get one of these reports, we need other medical reports that include details of the surgical findings. We also need medical documentation that you are dependent on daily parenteral nutrition to provide most of your nutritional requirements. F. How do we evaluate growth failure due to any digestive disorder under 105.08? 1. To evaluate growth failure due to any digestive disorder, we require documentation of the laboratory findings of chronic nutritional deficiency described in 105.08A and the growth measurements in 105.08B within the same consecutive 12-month period. The dates of laboratory findings may be different from the dates of growth measurements. 2. Under 105.08B, we evaluate a child’s growth failure by using the appropriate table for age and gender. a. For children from birth to attainment of age 2, we use the weight-for-length table (see Table I or Table II). b. For children age 2 to attainment of age 18, we use the body mass index (BMI)-for-age table (see Table III or Table IV). c. BMI is the ratio of your weight to the square of your height. We calculate BMI using one of the following formulas: English Formula BMI = [Weight in Pounds/(Height in Inches × Height in Inches)] × 703 Metric Formulas BMI = Weight in Kilograms/(Height in Meters × Height in Meters) BMI = [Weight in Kilograms/(Height in Centimeters × Height in Centimeters)] × 10,000 G. How do we evaluate digestive organ transplantation? If you receive a liver (105.09), small intestine (105.11), or pancreas E:\FR\FM\25JYP2.SGM 25JYP2 jspears on DSK30JT082PROD with PROPOSAL10 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules (105.12) transplant, we will consider you to be disabled under the listing for 1 year from the date of the transplant. After that, we evaluate your residual impairment(s) by considering the adequacy of your posttransplant function, the frequency and severity of any rejection episodes you have, complications in other body systems, and adverse treatment effects. People who receive digestive organ transplants generally have impairments that meet our definition of disability before they undergo transplantation. The phrase ‘‘consider under a disability for 1 year’’ in 105.09, 105.11, and 105.12 does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. H. How do we evaluate the need for supplemental daily enteral feeding via a gastrostomy? We evaluate the need for supplemental daily enteral feeding via a gastrostomy in children who have not attained age 3 under 105.10 regardless of the medical reason for the gastrostomy. After a child attains age 3, we evaluate growth failure due to any digestive disorder under 105.08, IBD requiring supplemental daily enteral or parenteral nutrition under 105.06, or other medical or developmental disorders under another digestive disorders listing or under a listing in an affected body system(s). I. How do we evaluate esophageal stricture or stenosis? Esophageal stricture or stenosis (narrowing) from congenital atresia (absence or abnormal closure of a tubular body organ) or destructive esophagitis may result in malnutrition or the need for gastrostomy placement, which we evaluate under 105.08 or 105.10. Esophageal stricture or stenosis may also result in complications such as pneumonias due to frequent aspiration, or difficulty in maintaining nutritional status short of listing level severity. While these individual complications usually do not meet the listing criteria, a combination of your impairments may medically equal a listing or functionally equal the listings. J. How do we evaluate your digestive disorder if there is no record of ongoing treatment? If there is no record of ongoing treatment despite the existence of a severe impairment(s), we will assess the severity and duration of your digestive disorder based on the current medical and other evidence in your case record. If there is no record of ongoing treatment, you may not be able to show an impairment that meets a digestive disorders listing, but your impairment may medically equal a listing, or be disabling based on our rules of functional equivalence. K. How do we evaluate your digestive disorder if there is evidence establishing a substance use disorder? If we find that you are disabled and there is medical evidence in your case record establishing that you have a substance use disorder, we will determine whether your substance use disorder is a contributing factor material to the determination of disability. See § 416.935 of this chapter. Digestive disorders resulting from drug or alcohol use are often chronic in nature and will not necessarily improve with cessation in drug or alcohol use. VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 L. How do we evaluate digestive disorders that do not meet one of these listings? 1. These listings are only examples of common digestive disorders that we consider severe enough to result in marked and severe functional limitations. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that satisfies the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See § 416.926 of this chapter. Digestive disorders may be associated with disorders in other body systems, and we consider the combined effects of multiple impairments when we determine whether they medically equal a listing. If your impairment(s) does not meet or medically equal a listing, we will also consider whether it functionally equals the listings. See § 416.926a of this chapter. We use the rules in § 416.994a of this chapter when we decide whether you continue to be disabled. 105.01 Category of Impairments, Digestive Disorders 105.02 Gastrointestinal hemorrhaging from any cause, requiring three blood transfusions of at least 10 cc of blood/kg of body weight per transfusion, within a consecutive 12-month period and at least 30 days apart. Consider under a disability for 1 year following the last documented transfusion; after that, evaluate the residual impairment(s). 105.03–105.04 [Reserved] 105.05 Chronic liver disease (CLD) (see 105.00C) with A, B, C, D, E, F, G, or H: A. Hemorrhaging from esophageal, gastric, or ectopic varices, or from portal hypertensive gastropathy (see 105.00C2a), documented by imaging (see 105.00B3); resulting in hemodynamic instability indicated by signs such as pallor (pale skin), diaphoresis (profuse perspiration), rapid pulse, low blood pressure, postural hypotension (pronounced fall in blood pressure when arising to an upright position from lying down, or syncope (fainting); and requiring hospitalization for transfusion of at least 10 cc of blood/kg of body weight. Consider under a disability for 1 year following the documented transfusion; after that, evaluate the residual impairment(s). OR B. Ascites or hydrothorax not attributable to other causes (see 105.00C2b), present on two evaluations within a consecutive 12month period and at least 60 days apart. Each evaluation must document the ascites or hydrothorax by 1, 2, or 3: 1. Paracentesis; or 2. Thoracentesis; or 3. Imaging or physical examination with a or b: a. Serum albumin of 3.0 g/dL or less; or b. INR of at least 1.5. OR C. Spontaneous bacterial peritonitis (see 105.00C2c) documented by peritoneal fluid containing a neutrophil count of at least 250 cells/mm3. OR PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 35953 D. Hepatorenal syndrome (see 105.00C2d) documented by 1, 2, or 3: 1. Serum creatinine elevation of at least 2 mg/dL; or 2. Oliguria with 24-hour urine output less than 1 mL/kg/hr; or 3. Sodium retention with urine sodium less than 10 mEq per liter. OR E. Hepatopulmonary syndrome (see 105.00C2e) documented by 1 or 2: 1. Arterial PaO2 measured by an ABG test, while at rest, breathing room air, less than or equal to: a. 60 mm Hg, at test sites less than 3,000 feet above sea level; or b. 55 mm Hg, at test sites from 3,000 through 6,000 feet above sea level; or c. 50 mm Hg, at test sites over 6,000 feet above sea level; or 2. Intrapulmonary arteriovenous shunting as shown on contrast-enhanced echocardiography or macroaggregated albumin lung perfusion scan. OR F. Hepatic encephalopathy (see 105.00C2f) with documentation of abnormal behavior, cognitive dysfunction, changes in mental status, or altered state of consciousness (for example, confusion, delirium, stupor, or coma), present on two evaluations within a consecutive 12-month period and at least 60 days apart and either 1 or 2: 1. History of transjugular intrahepatic portosystemic shunt (TIPS) or other surgical portosystemic shunt; or 2. One of the following on at least two evaluations at least 60 days apart within the same consecutive 12-month period as in F: a. Asterixis or other fluctuating physical neurological abnormalities; or b. EEG demonstrating triphasic slow wave activity; or c. Serum albumin of 3.0 g/dL or less; or d. INR of 1.5 or greater. OR G. SSA CLD or SSA CLD–P scores (see 105.00C3): 1. For children age 12 or older, two SSA CLD or SSA CLD–P scores of at least 20 within a consecutive 12-month period and at least 60 days apart; or 2. For children who have not attained age 12, one SSA CLD–P score of at least 11. OR H. Extrahepatic biliary atresia as diagnosed on liver biopsy or intraoperative cholangiogram (see 105.00C4). Consider under a disability for 1 year following diagnosis; after that, evaluate the residual impairment(s). 105.06 Inflammatory bowel disease (IBD) (see 105.00D) documented by endoscopy, biopsy, imaging, or operative findings and demonstrated by A or B: A. Obstruction of stenotic areas (not adhesions) in the small intestine or colon with proximal dilatation, confirmed by imaging or in surgery, requiring two hospitalizations for intestinal decompression or for surgery, within a consecutive 12-month period and at least 60 days apart. OR E:\FR\FM\25JYP2.SGM 25JYP2 35954 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules B. Two of the following occurring within a consecutive 12-month period and at least 60 days apart: 1. Clinically documented tender abdominal mass palpable on physical examination with abdominal pain or cramping; or 2. Perineal disease with a draining abscess or fistula; or 3. Need for supplemental daily enteral nutrition via a gastrostomy or daily parenteral nutrition via a central venous catheter (see 105.10 for children who have not attained age 3). 105.07 Short bowel syndrome (SBS) (see 105.00E) due to surgical resection of any amount of the small intestine, resulting in dependence on daily parenteral nutrition via a central venous catheter. 105.08 Growth failure due to any digestive disorder (see 105.00F), documented by A and B: A. Chronic nutritional deficiency present on two evaluations within a consecutive 12month period and at least 60 days apart documented by 1 or 2: 1. Anemia with hemoglobin less than 10.0 g/dL; or 2. Serum albumin of 3.0 g/dL or less. AND B. Growth failure as required in 1 or 2: 1. For children from birth to attainment of age 2, three weight-for-length measurements that are: a. Within a consecutive 12-month period; and b. At least 60 days apart; and c. Less than the third percentile values in Table I or Table II; or TABLE I—MALES BIRTH TO ATTAINMENT OF AGE 2 [Third percentile values for weight-for-length] Length (centimeters) Weight (kilograms) Length (centimeters) Weight (kilograms) Length (centimeters) Weight (kilograms) 45.0 45.5 46.5 47.5 48.5 49.5 50.5 51.5 52.5 53.5 54.5 55.5 56.5 57.5 58.5 59.5 60.5 61.5 62.5 63.5 1.597 1.703 1.919 2.139 2.364 2.592 2.824 3.058 3.294 3.532 3.771 4.010 4.250 4.489 4.728 4.966 5.203 5.438 5.671 5.903 64.5 65.5 66.5 67.5 68.5 69.5 70.5 71.5 72.5 73.5 74.5 75.5 76.5 77.5 78.5 79.5 80.5 81.5 82.5 83.5 6.132 6.359 6.584 6.807 7.027 7.245 7.461 7.674 7.885 8.094 8.301 8.507 8.710 8.913 9.113 9.313 9.512 9.710 9.907 10.104 84.5 85.5 86.5 87.5 88.5 89.5 90.5 91.5 92.5 93.5 94.5 95.5 96.5 97.5 98.5 99.5 100.5 101.5 102.5 103.5 10.301 10.499 10.696 10.895 11.095 11.296 11.498 11.703 11.910 12.119 12.331 12.546 12.764 12.987 13.213 13.443 13.678 13.918 14.163 14.413 TABLE II—FEMALES BIRTH TO ATTAINMENT OF AGE 2 jspears on DSK30JT082PROD with PROPOSAL10 [Third percentile values for weight-for-length] Length (centimeters) Weight (kilograms) Length (centimeters) Weight (kilograms) Length (centimeters) Weight (kilograms) 45.0 45.5 46.5 47.5 48.5 49.5 50.5 51.5 52.5 53.5 54.5 55.5 56.5 57.5 58.5 59.5 60.5 61.5 62.5 63.5 1.613 1.724 1.946 2.171 2.397 2.624 2.852 3.081 3.310 3.538 3.767 3.994 4.220 4.445 4.669 4.892 5.113 5.333 5.552 5.769 64.5 65.5 66.5 67.5 68.5 69.5 70.5 71.5 72.5 73.5 74.5 75.5 76.5 77.5 78.5 79.5 80.5 81.5 82.5 83.5 5.985 6.200 6.413 6.625 6.836 7.046 7.254 7.461 7.667 7.871 8.075 8.277 8.479 8.679 8.879 9.078 9.277 9.476 9.674 9.872 84.5 85.5 86.5 87.5 88.5 89.5 90.5 91.5 92.5 93.5 94.5 95.5 96.5 97.5 98.5 99.5 100.5 101.5 102.5 103.5 10.071 10.270 10.469 10.670 10.871 11.074 11.278 11.484 11.691 11.901 12.112 12.326 12.541 12.760 12.981 13.205 13.431 13.661 13.895 14.132 2. For children age 2 to attainment of age 18, three BMI-for-age measurements that are: VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 a. Within a consecutive 12-month period; and b. At least 60 days apart; and PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 c. Less than the third percentile value in Table III or Table IV. E:\FR\FM\25JYP2.SGM 25JYP2 35955 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules TABLE III—MALES AGE 2 TO ATTAINMENT OF AGE 18 [Third percentile values for BMI-for-age] Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI 2.0 to 2.1 2.2 to 2.4 2.5 to 2.7 2.8 to 2.11 3.0 to 3.2 3.3 to 3.6 3.7 to 3.11 4.0 to 4.5 4.6 to 5.0 5.1 to 6.0 6.1 to 7.6 7.7 to 8.6 8.7 to 9.1 9.2 to 9.6 9.7 to 9.11 10.0 to 10.3 10.4 to 10.7 10.8 to 10.10 14.5 14.4 14.3 14.2 14.1 14.0 13.9 13.8 13.7 13.6 13.5 13.6 13.7 13.8 13.9 14.0 14.1 14.2 10.11 to 11.2 11.3 to 11.5 11.6 to 11.8 11.9 to 11.11 12.0 to 12.1 12.2 to 12.4 12.5 to 12.7 12.8 to 12.9 12.10 to 13.0 13.1 to 13.2 13.3 to 13.4 13.5 to 13.7 13.8 to 13.9 13.10 to 13.11 14.0 to 14.1 14.2 to 14.4 14.5 to 14.6 14.7 to 14.8 14.3 14.4 14.5 14.6 14.7 14.8 14.9 15.0 15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9 16.0 14.9 to 14.10 14.11 to 15.0 15.1 to 15.3 15.4 to 15.5 15.6 to 15.7 15.8 to 15.9 15.10 to 15.11 16.0 to 16.1 16.2 to 16.3 16.4 to 16.5 16.6 to 16.8 16.9 to 16.10 16.11 to 17.0 17.1 to 17.2 17.3 to 17.5 17.6 to 17.7 17.8 to 17.9 17.10 to 17.11 16.1 16.2 16.3 16.4 16.5 16.6 16.7 16.8 16.9 17.0 17.1 17.2 17.3 17.4 17.5 17.6 17.7 17.8 TABLE IV—FEMALES AGE 2 TO ATTAINMENT OF AGE 18 jspears on DSK30JT082PROD with PROPOSAL10 [Third percentile values for BMI-for-age] Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI 2.0 to 2.2 2.3 to 2.6 2.7 to 2.10 2.11 to 3.2 3.3 to 3.6 3.7 to 3.11 4.0 to 4.4 4.5 to 4.11 5.0 to 5.9 5.10 to 7.6 7.7 to 8.4 8.5 to 8.10 8.11 to 9.3 9.4 to 9.8 9.9 to 10.0 10.1 to 10.4 10.5 to 10.7 14.1 14.0 13.9 13.8 13.7 13.6 13.5 13.4 13.3 13.2 13.3 13.4 13.5 13.6 13.7 13.8 13.9 10.8 to 10.10 10.11 to 11.2 11.3 to 11.5 11.6 to 11.7 11.8 to 11.10 11.11 to 12.1 12.2 to 12.4 12.5 to 12.6 12.7 to 12.9 12.10 to 12.11 13.0 to 13.2 13.3 to 13.4 13.5 to 13.7 13.8 to 13.9 13.10 to 14.0 14.1 to 14.2 ................................... 14.0 14.1 14.2 14.3 14.4 14.5 14.6 14.7 14.8 14.9 15.0 15.1 15.2 15.3 15.4 15.5 ................................... 14.3 to 14.5 14.6 to 14.7 14.8 to 14.9 14.10 to 15.0 15.1 to 15.2 15.3 to 15.5 15.6 to 15.7 15.8 to 15.10 15.11 to 16.0 16.1 to 16.3 16.4 to 16.6 16.7 to 16.9 16.10 to 17.0 17.1 to 17.3 17.4 to 17.7 17.8 to 17.11 ................................... 15.6 15.7 15.8 15.9 16.0 16.1 16.2 16.3 16.4 16.5 16.6 16.7 16.8 16.9 17.0 17.1 ................................... 105.09 Liver transplantation (see 105.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). 105.10 Need for supplemental daily enteral feeding via a gastrostomy (see 105.00H) due to any cause, for children who have not attained age 3; after that, evaluate the residual impairment(s). 105.11 Small intestine transplantation (see 105.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). 105.12 Pancreas transplantation (see 105.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). * * 108.00 * * * Skin Disorders A. Which skin disorders do we evaluate under these listings? We use these listings to evaluate skin disorders that result from VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 hereditary, congenital, or acquired pathological processes. We evaluate genetic photosensitivity disorders (108.07), burns (108.08), and chronic conditions of the skin or mucous membranes such as ichthyosis, bullous disease, dermatitis, psoriasis, and hidradenitis suppurativa (108.09). B. What are our definitions for the following terms used in this body system? 1. Assistive device(s): An assistive device, for the purposes of these listings, is any device that is used to improve stability, dexterity, or mobility. An assistive device can be hand-held, such as a cane(s), a crutch(es), or a walker; or worn, such as a prosthesis or an orthosis. 2. Chronic skin lesions: Chronic skin lesions can have recurrent exacerbations. They can occur despite prescribed medical treatment. These chronic skin lesions can develop on any part of your body, including upper extremities, lower extremities, palms of your hands, soles of your feet, the perineum, inguinal (groin) region, and axillae PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 (underarms). Chronic skin lesions may result in functional limitations as described in 108.00D2. 3. Contractures: Contractures are permanent fibrous scar tissue resulting in tightening and thickening of skin that prevents normal movement of the damaged area. They can develop on any part of your musculoskeletal system, including upper extremities, lower extremities, palms of your hands, soles of your feet, the perineum, inguinal (groin) region, and axillae (underarms). Contractures may result in functional limitations as described in 108.00D2. 4. Documented medical need: When we use the term ‘‘documented medical need,’’ we mean that there is evidence from your medical source(s) in the medical record that supports your need for an assistive device (see § 416.913 of this chapter). The evidence must include documentation from your medical source(s) describing any limitation(s) in your upper or lower extremity functioning E:\FR\FM\25JYP2.SGM 25JYP2 jspears on DSK30JT082PROD with PROPOSAL10 35956 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules that supports your need for the assistive device, and describing the circumstances for which you need it. The evidence does not have to include a specific prescription for the device. 5. Fine and gross movements: Fine movements, for the purposes of these listings, involve use of your wrists, hands, and fingers; such movements include picking, pinching, manipulating, and fingering. Gross movements involve use of your shoulders, upper arms, forearms, and hands; such movements include handling, gripping, grasping, holding, turning, and reaching. Gross movements also include exertional activities such as lifting, carrying, pushing, and pulling. Evaluation of fine and gross movements is dependent on your age. 6. Surgical management: For the purposes of these listings, surgical management includes the surgery(-ies) itself, as well as various post-surgical procedures, surgical complications, infections or other medical complications, related illnesses, or related treatments that delay a person’s attainment of maximum benefit from surgery. C. What evidence do we need to evaluate your skin disorder? 1. To establish the presence of a skin disorder as a medically determinable impairment, we need objective medical evidence from an acceptable medical source who has examined you for the disorder. 2. We will make every reasonable effort to obtain your medical history, treatment records, and relevant laboratory findings, but we will not purchase genetic testing. 3. When we evaluate the presence and severity of your skin disorder(s), we generally need information regarding: a. The onset, duration, and frequency of exacerbations; b. The prognosis of your skin disorder; c. The location, size, and appearance of lesions and contractures; d. Your history of familial incidence; exposure to toxins, allergens or irritants; seasonal variations; and stress factors; e. Your ability to function outside of a highly protective environment; f. Laboratory findings (for example, a biopsy obtained independently of Social Security disability evaluation or results of blood tests); g. Evidence from other medically acceptable methods consistent with the prevailing state of medical knowledge and clinical practice; and h. Statements you or others make about your disorder(s), your restrictions, and your daily activities. D. How do we evaluate the severity of skin disorders? 1. General. We evaluate the severity of skin disorders based on the site(s) of your chronic skin lesions or contractures, functional limitations caused by your signs and symptoms (including pain) (see 108.00D2), and how your prescribed treatment affects you. We consider the frequency and severity of your exacerbations, how quickly they resolve, and how you function between exacerbations, to determine whether your skin disorder meets or medically equals a listing. If there is no record of ongoing medical treatment for your disorder, we will VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 follow the guidelines in 108.00D6. We will determine the extent and kinds of evidence we need from medical and non-medical sources based on the individual facts about your disorder. For our basic rules on evidence, see §§ 416.912, 416.913, and 416.920b of this chapter. For our rules on evaluating your symptoms, see § 416.929 of this chapter. 2. Limitation(s) of physical functioning due to skin disorders. a. Skin disorders may be due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3), and may cause pain or restrict movement, which can limit your ability to initiate, sustain, and complete ageappropriate activities. For example, skin lesions in the axilla may limit your ability to raise or reach with the affected arm, or lesions in the inguinal region may limit your ability to ambulate, sit, or lift and carry. To evaluate your skin disorder(s) under 108.07B, 108.08, and 108.09, we require medically documented evidence of physical limitation(s) of functioning related to your disorder. The decrease in physical function must have lasted, or can be expected to last, for a continuous period of at least 12 months (see § 416.909 of this chapter). Xeroderma pigmentosum is the only skin disorder that does not include functional criteria because the characteristics and severity of the disorder itself are sufficient to meet the criteria in 108.07A. b. The functional criteria require impairment-related physical limitations in using upper or lower extremities that have lasted, or can be expected to last, for a continuous period of at least 12 months, medically documented by one of the following: (i) Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements; (ii) Inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements due to chronic skin lesions or contractures, and a documented medical need for a one-handed assistive device that requires the use of your other upper extremity; or (iii) Inability to stand up from a seated position and maintain an upright position to the extent you can independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions or contractures affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or (iv) Inability to maintain an upright position while standing or walking, to independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions or contractures affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 3. Frequency of exacerbations due to chronic skin lesions. A skin disorder resulting in chronic skin lesions (see 108.00B2) may have frequent exacerbations severe enough to meet a listing even if each PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 individual skin lesion exacerbation did not last for an extended amount of time. We will consider the frequency, severity, and duration of skin lesion exacerbations; how quickly they resolve; and how you function in the time between skin lesion exacerbations, to determine whether your skin disorder meets or medically equals a listing. 4. Symptoms (including pain). Your symptoms may be an important factor in our determination of whether your skin disorder(s) meets or medically equals a listing. We consider your symptoms only when you have a medically determinable impairment(s) that could reasonably be expected to produce the symptoms. See § 416.929 of this chapter. 5. Treatment. a. General. Treatments for skin disorders may have beneficial or adverse effects, and responses to treatment vary from person to person. Your skin disorder’s response to treatment may vary due to treatment resistance or side effects that can result in functional limitations. We will evaluate all of the effects of treatment (including surgical treatment, medications, and therapy) on the symptoms, signs, and laboratory findings of your skin disorder, and on your ability to function. b. Despite adherence to prescribed medical treatment for 3 months. Under 108.09, we require that your symptoms persist ‘‘despite adherence to prescribed medical treatment for 3 months.’’ This requirement means that you must have taken prescribed medication(s) or followed other medical treatment prescribed by a physician for 3 consecutive months. Treatment or effects of treatment may be temporary. In most cases, sufficient time must elapse to allow us to evaluate your response to treatment, including any side effects. For our purposes, ‘‘sufficient time’’ means a period of at least three months. If your treatment has not lasted for at least 3 months, we will follow the rules in 108.00D6a. To evaluate the severity of physical limitations due to your skin disorder(s), we require medically documented evidence of disorder-related physical limitation(s) of functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months. See § 416.909 of this chapter. The 3 months adherence to prescribed medical treatment must be within the period of at least 12 months that we use to evaluate severity. c. Treatment with PUVA (psoralen and ultraviolet A (UVA) light) or biologics. If you receive additional treatment with PUVA or biologics to treat your skin disorder(s), we will defer adjudication of your claim for 6 months from the start of treatment with PUVA or biologics to evaluate the effectiveness of these treatments unless we can make a fully favorable determination or decision on another basis. 6. No record of ongoing treatment. a. Despite having a skin disorder, you may not have received ongoing treatment, may have just begun treatment, may not have access to prescribed medical treatment, or may not have an ongoing relationship with the medical community. In any of these situations, you will not have a longitudinal E:\FR\FM\25JYP2.SGM 25JYP2 jspears on DSK30JT082PROD with PROPOSAL10 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules medical record for us to review when we evaluate your disorder. In some instances, we may be able to assess the severity and duration of your skin disorder based on your medical record and current evidence alone. We may ask you to attend a consultative examination to determine the severity and potential duration of your skin disorder (see § 416.919a of this chapter). b. If, for any reason, you have not received treatment, your skin disorder cannot meet the criteria for 108.09. If the information in your case record is not sufficient to show that you have a skin disorder that meets the criteria of one of the skin disorders listings, we will follow the rules in 108.00I. E. How do we evaluate genetic photosensitivity disorders under 108.07? Genetic photosensitivity disorders are disorders of the skin caused by an increase in the sensitivity of the skin to sources of ultraviolet light, including sunlight. 1. Xeroderma pigmentosum (XP) (108.07A). XP is a genetic photosensitivity disorder with lifelong hypersensitivity to all forms of ultraviolet light. Laboratory testing confirms the diagnosis by documenting abnormalities in the body’s ability to repair DNA (deoxyribonucleic acid) mutations after ultraviolet light exposure. Your skin disorder meets the requirements of 108.07A if you have clinical and laboratory findings supporting a diagnosis of XP (see 108.00E3). 2. Other genetic photosensitivity disorders (108.07B). The effects of other genetic photosensitivity disorders may vary and may not persist over time. To meet the requirements of 108.07B, a genetic photosensitivity disorder other than XP must be established by clinical and laboratory findings (see 108.00C) and either must result in chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) that result in functional limitations (108.00D), or must result in the inability to function outside of a highly protective environment. Some genetic photosensitivity disorders can have very serious effects on other body systems, especially special senses and speech, neurological, mental, and cancer. We will evaluate your disorder(s) under the listings in 102.00, 111.00, 112.00, or 113.00, as appropriate. 3. What evidence do we need to document that you have XP or another genetic photosensitivity disorder? We will make a reasonable effort to obtain evidence of your disorder(s), but we will not purchase genetic testing. When the results of genetic tests are part of the existing evidence in your case record, we will evaluate the test results with all other relevant evidence. We need the following clinical and laboratory findings to document that you have XP or another genetic photosensitivity disorder: a. A laboratory report of a definitive genetic laboratory test documenting appropriate chromosomal changes, including abnormal DNA repair or another DNA abnormality specific to your type of photosensitivity disorder, signed by an acceptable medical source (AMS); or b. A laboratory report of a definitive test that is not signed by an AMS, and a report from an AMS stating that you have undergone definitive genetic laboratory VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 studies documenting appropriate chromosomal changes, including abnormal DNA repair or another DNA abnormality specific to your type of photosensitivity disorder; or c. If we do not have a laboratory report of a definitive test, we need documentation from an AMS that an appropriate laboratory analysis or other diagnostic method(s) confirms a positive diagnosis of your skin disorder. This documentation must state that you had the appropriate definitive laboratory test(s) for diagnosing your disorder and provide the results, or explain how another diagnostic method(s), consistent with the prevailing state of medical knowledge and clinical practice, established your diagnosis. 4. Inability to function outside of a highly protective environment means that you must avoid exposure to ultraviolet light (including sunlight passing through windows and light from similar unshielded light sources), wear protective clothing and eyeglasses, and use opaque broad-spectrum sunscreens in order to avoid skin cancer or other serious effects. F. How do we evaluate burns under 108.08? 1. Electrical, chemical, or thermal burns frequently affect other body systems; for example, musculoskeletal, special senses and speech, respiratory, cardiovascular, genitourinary, neurological, or mental. We evaluate burns in the same way we evaluate other disorders that can affect the skin and other body systems, using the listing for the predominant feature of your disorder. For example, if your soft tissue injuries resulting from burns are under surgical management (as defined in 108.00B6), we will evaluate your disorder under the listings in 101.00. 2. We evaluate third-degree burns resulting in contractures (see 108.00B3) that have been documented by an acceptable medical source to have reached maximum therapeutic benefit and therefore are no longer receiving surgical management, under 108.08. To be disabling, these burns must result in functional limitation(s) (see 108.00D2) that has lasted or can be expected to last for a continuous period of at least 12 months. G. How do we evaluate chronic conditions of the skin or mucous membranes under 108.09? We evaluate skin disorders that result in chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) under 108.09. These disorders must result in chronic skin lesions or contractures that continue to persist despite adherence to prescribed medical treatment for 3 months (see 108.00D5b) and cause functional limitations (see 108.00D2). Examples of skin disorders evaluated under this listing are ichthyosis, bullous diseases (such as pemphigus, epidermolysis bullosa, and dermatitis herpetiformis), chronic skin infections, dermatitis, psoriasis, and hidradenitis suppurativa. H. How do we evaluate disorders in other body systems that affect the skin? When your disorder(s) in another body system affects the skin, we first evaluate the predominant feature of your disorder(s) under the appropriate body system. Examples of disorders in other body systems that affect the skin include the following: 1. Tuberous sclerosis. The predominant functionally limiting features of tuberous PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 35957 sclerosis are seizures and intellectual disability or other mental disorders. We evaluate these features under the listings in 111.00 or 112.00, as appropriate. 2. Malignant tumors of the skin. Malignant tumors of the skin (for example, malignant melanomas) are cancers, or malignant neoplastic diseases, that we evaluate under the listings in 113.00. 3. Immune system disorders. We evaluate skin manifestations of immune system disorders such as systemic lupus erythematosus, scleroderma, psoriasis, and human immunodeficiency virus (HIV) infection under the listings in 114.00. 4. Head or facial disfigurement or deformity, and other physical deformities caused by skin disorders. A head or facial disfigurement or deformity may result in loss of your sight, hearing, speech, or ability to chew. In addition to head and facial disfigurement and deformity, other physical deformities may result in associated psychological problems (for example, depression). We evaluate the effects of head or facial disfigurement or deformity, or other physical deformities caused by skin disorders under the listings in 101.00, 102.00, 105.00, or 112.00, as appropriate. 5. Porphyria. We evaluate erythropoietic protoporphyria under the listings in 107.00. 6. Hemangiomas. We evaluate hemangiomas associated with thrombocytopenia and hemorrhage (for example, Kasabach-Merritt syndrome) involving coagulation defects under the listings in 107.00. When hemangiomas impinge on vital structures or interfere with functioning, we evaluate their primary effects under the listings in the appropriate body system. I. How do we evaluate skin disorders that do not meet one of these listings? 1. These listings are only examples of common skin disorders that we consider severe enough to result in marked and severe limitations. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that satisfies the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See § 416.926 of this chapter. If your impairment(s) does not meet or medically equal a listing, we will also consider whether your impairment(s) functionally equals the listings. See § 416.926a of this chapter. We use the rules in § 416.994a of this chapter when we decide whether you continue to be disabled. 108.01 Category of Impairments, Skin Disorders 108.02–108.06 [Reserved] 108.07 Genetic photosensitivity disorders, established as described in 108.00E. The requirements of this listing are met if either paragraph A or paragraph B is satisfied. A. Xeroderma pigmentosum (see 108.00E1). OR B. Other genetic photosensitivity disorders (see 108.00E2) with either 1 or 2: 1. Chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) that cause an E:\FR\FM\25JYP2.SGM 25JYP2 35958 Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Proposed Rules jspears on DSK30JT082PROD with PROPOSAL10 inability to function outside of a highly protective environment (see 108.00E4); or 2. Chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) that cause functional limitations (see 108.00D2) due to limitation(s) from your skin condition, such as pain, as evidenced by: a. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements; or b. Inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (due to chronic skin lesions or contractures), and a documented medical need for a one-handed assistive device that requires the use of your other upper extremity; or c. Inability to stand up from a seated position and maintain an upright position to the extent you can independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions or contractures affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or d. Inability to maintain an upright position while standing or walking, to independently initiate, sustain, and complete ageappropriate activities due to chronic skin lesions or contractures affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 108.08 Burns (see 108.00F). Third-degree burns that do not require continuing surgical management, or that have been documented by an acceptable medical source to have reached maximum therapeutic benefit and are no longer receiving surgical management, resulting in chronic skin lesions (see VerDate Sep<11>2014 17:22 Jul 24, 2019 Jkt 247001 108.00B2) or contractures (see 108.00B3) that cause functional limitations (see 108.00D2) due to limitation(s), such as pain, from your skin condition, as evidenced by: A. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements. OR B. Inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (due to chronic skin lesions or contractures), and a documented medical need for a one-handed assistive device that requires the use of your other upper extremity. OR C. Inability to stand up from a seated position and maintain an upright position to the extent you can independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions or contractures affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region). OR D. Inability to maintain an upright position while standing or walking, to independently initiate, sustain, and complete ageappropriate activities due to chronic skin lesions or contractures affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 108.09 Chronic conditions of the skin or mucous membranes (see 108.00G) resulting in: A. Chronic skin lesions (see 108.00B2) or contractures (see 108.00B3); chronic pain; or other physical limitation(s); that persist PO 00000 Frm 00024 Fmt 4701 Sfmt 9990 despite adherence to prescribed medical treatment for 3 months (see 108.00D5b), causing functional limitations (see 108.00D2) due to limitation(s), such as pain, from your skin condition. AND B. Impairment-related significant limitation demonstrated by 1, 2, 3, or 4: 1. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements; or 2. Inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (due to chronic skin lesions or contractures), and a documented medical need for a one-handed assistive device that requires the use of your other upper extremity; or 3. Inability to stand up from a seated position and maintain an upright position to the extent you can independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions or contractures affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or 4. Inability to maintain an upright position while standing or walking, to independently initiate, sustain, and complete ageappropriate activities due to chronic skin lesions or contractures affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). * * * * * [FR Doc. 2019–15554 Filed 7–24–19; 8:45 am] BILLING CODE P E:\FR\FM\25JYP2.SGM 25JYP2

Agencies

[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Proposed Rules]
[Pages 35936-35958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15554]



[[Page 35935]]

Vol. 84

Thursday,

No. 143

July 25, 2019

Part II





Social Security Administration





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20 CFR Part 404





Revised Medical Criteria for Evaluating Digestive Disorders and Skin 
Disorders; Proposed Rule

Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / 
Proposed Rules

[[Page 35936]]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Docket No. SSA-2017-0042]
RIN 0960-AG65


Revised Medical Criteria for Evaluating Digestive Disorders and 
Skin Disorders

AGENCY: Social Security Administration.

ACTION: Notice of proposed rulemaking.

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SUMMARY: We propose to revise the criteria in the Listing of 
Impairments (listings) that we use to evaluate claims involving 
digestive and skin disorders in adults and children under titles II and 
XVI of the Social Security Act (Act). The proposed revisions reflect 
our adjudicative experience, advances in medical knowledge, and 
comments we received from experts and the public in response to two 
advance notices of proposed rulemaking (ANPRM).

DATES: To ensure that your comments are considered, we must receive 
them by no later than September 23, 2019.

ADDRESSES: You may submit comments by any one of three methods--
internet, fax, or mail. Do not submit the same comments multiple times 
or by more than one method. Regardless of which method you choose, 
please state that your comments refer to Docket No. SSA-2017-0042, so 
that we may associate your comments with the correct regulation.
    Caution: You should be careful to include in your comments only 
information that you wish to make publicly available. We strongly urge 
you not to include in your comments any personal information, such as 
Social Security numbers or medical information.
    1. Internet: We strongly recommend that you submit your comments 
via the internet. Please visit the Federal eRulemaking portal at http://www.regulations.gov. Use the Search function to find docket number 
SSA-2017-0042. The system will issue a tracking number to confirm your 
submission. You will not be able to view your comment immediately 
because we must post each comment manually. It may take up to a week 
for your comment to be viewable.
    2. Fax: Fax comments to (410) 966-2830.
    3. Mail: Address your comments to the Office of Regulations and 
Reports Clearance, Social Security Administration, 3100 West High Rise, 
6401 Security Boulevard, Baltimore, Maryland 21235-6401.
    Comments are available for public viewing on the Federal 
eRulemaking portal at http://www.regulations.gov or in person, during 
regular business hours, by arranging with the contact person identified 
below.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of 
Disability Policy, Social Security Administration, 6401 Security 
Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1020. For 
information on eligibility or filing for benefits, call our national 
toll-free number, 1-800-772-1213, or TTY 1-800-325-0778, or visit our 
internet site, Social Security Online, at http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION: 

Why are we proposing to revise the listings for digestive and skin 
disorders?

    We last published final rules that revised the digestive disorders 
listings on October 19, 2007, and the skin disorders listings on June 
9, 2004.\1\ We are proposing these revisions to reflect our 
adjudicative experience, advances in medical knowledge, and comments we 
received from experts and the public in response to two ANPRMs.
---------------------------------------------------------------------------

    \1\ See 72 FR 59398 (2007) and 69 FR 32260 (2004).
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How did we develop these proposed rules?

    In developing these proposed rules:
     We published an ANPRM for digestive disorders in the 
Federal Register on December 12, 2007.\2\ We invited the public to 
comment on whether we should add a digestive disorders listing based on 
functional limitations and, if so, what criteria we should use. We 
received 12 comments. Ten commenters recommended adding a digestive 
disorders listing with functional criteria and suggested we use the 
same functional criteria we use in other body systems.
---------------------------------------------------------------------------

    \2\ See 72 FR 70527.
---------------------------------------------------------------------------

     We published an ANPRM for skin disorders in the Federal 
Register on November 10, 2009.\3\ We invited the public to send us 
written comments and suggestions about whether and how we should revise 
the skin disorders listings. We received three comments.
---------------------------------------------------------------------------

    \3\ See 74 FR 57972, with the docket number corrected at 74 FR 
62518.
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    The comments we received from these two ANPRMs informed the 
proposed changes in this NPRM. In developing these proposed rules, we 
also considered information from several other sources, including:
     Medical experts in gastroenterology and dermatology;
     Advocacy groups for people with digestive and skin 
disorders;
     People with digestive and skin disorders and their 
families;
     People who make and review disability determinations and 
decisions for us in State agencies, in our Office of Hearings 
Operations, and in our Office of Analytics, Review, and Oversight; and
     The published sources we list in the References section at 
the end of this preamble.

How is this NPRM organized?

Digestive Disorders Overview of Proposed Revisions
     Adult digestive disorders proposed revisions
     Child digestive disorders proposed revisions

    The following chart shows the heading of the current and proposed 
sections of the adult introductory text and listings for digestive 
disorders:

------------------------------------------------------------------------
     Current sections of the adult        Proposed sections of the adult
 introductory text and listings for the   introductory text and listings
            digestive system                 for digestive disorders
------------------------------------------------------------------------
                         Introductory Text, 5.00
------------------------------------------------------------------------
A. What kinds of disorders do we         A. Which digestive disorders do
 consider in the digestive system?.       we evaluate in this body
                                          system?
B. What documentation do we need?......  B. What evidence do we need to
                                          evaluate your digestive
                                          disorder?
C. How do we consider the effects of     [5.00 H.]
 treatment?.
D. How do we evaluate chronic liver      C. What is chronic liver
 disease?.                                disease (CLD), and how do we
                                          evaluate it under 5.05?
E. How do we evaluate inflammatory       D. What is inflammatory bowel
 bowel disease (IBD)?.                    disease (IBD), and how do we
                                          evaluate it under 5.06?
F. How do we evaluate short bowel        E. What is short bowel syndrome
 syndrome (SBS)?.                         (SBS), and how do we evaluate
                                          it under 5.07?

[[Page 35937]]

 
G. How do we evaluate weight loss due    F. How do we evaluate
 to any digestive disorder?.              malnutrition due to any
                                          digestive disorder under 5.08?
[5.00 D.12.]...........................  G. How do we evaluate digestive
                                          organ transplantation?
H. What do we mean by the phrase         [5.00 C.2. and G.]
 ``consider under a disability for 1
 year''?
[5.00 C.6.]............................  H. How do we evaluate your
                                          digestive disorder if there is
                                          no record of ongoing
                                          treatment?
                                         I. How do we evaluate your
                                          digestive disorder if there is
                                          evidence establishing a
                                          substance use disorder?
I. How do we evaluate impairments that   J. How do we evaluate digestive
 do not meet one of the digestive         disorders that do not meet one
 disorder listings?                       of these listings?
------------------------------------------------------------------------
                                Listings
------------------------------------------------------------------------
5.01 Category of Impairments, Digestive  5.01 Category of Impairments,
 System.                                  Digestive Disorders
5.02 Gastrointestinal hemorrhaging from  5.02 Gastrointestinal
 any cause, requiring blood transfusion.  hemorrhaging from any cause,
                                          requiring three blood
                                          transfusions
5.03 [Reserved]........................  5.03 [Reserved]
5.04 [Reserved]........................  5.04 [Reserved]
5.05 Chronic liver disease (CLD).......  5.05 Chronic liver disease
                                          (CLD)
5.06 Inflammatory bowel disease (IBD)..  5.06 Inflammatory bowel disease
                                          (IBD)
5.07 Short bowel syndrome (SBS)........  5.07 Short bowel syndrome (SBS)
5.08 Weight loss due to any digestive    5.08 Malnutrition due to any
 disorder.                                digestive disorder
5.09 Liver transplantation.............  5.09 Liver transplantation
                                         5.10 [Reserved]
                                         5.11 Small intestine
                                          transplantation
                                         5.12 Pancreas transplantation
------------------------------------------------------------------------

    The following chart shows the heading of the current and proposed 
sections of the child introductory text and listings for digestive 
disorders:

------------------------------------------------------------------------
     Current sections of the child        Proposed sections of the child
 introductory text and listings for the   introductory text and listings
            digestive system                 for digestive disorders
------------------------------------------------------------------------
                        Introductory Text, 105.00
------------------------------------------------------------------------
A. What kinds of disorders do we         A. Which digestive disorders do
 consider in the digestive system?.       we evaluate in this body
                                          system?
B. What documentation do we need?......  B. What evidence do we need to
                                          evaluate your digestive
                                          disorder?
C. How do we consider the effects of     [105.00 J.]
 treatment?.
D. How do we evaluate chronic liver      C. What is chronic liver
 disease?.                                disease (CLD), and how do we
                                          evaluate it under 105.05?
E. How do we evaluate inflammatory       D. What is inflammatory bowel
 bowel disease (IBD)?.                    disease (IBD), and how do we
                                          evaluate it under 105.06?
F. How do we evaluate short bowel        E. What is short bowel syndrome
 syndrome (SBS)?.                         (SBS), and how do we evaluate
                                          it under 105.07?
G. How do we evaluate growth failure     F. How do we evaluate growth
 due to any digestive disorder?.          failure due to any digestive
                                          disorder under 105.08?
[105.00 D.13.].........................  G. How do we evaluate digestive
                                          organ transplantation?
H. How do we evaluate the need for       H. How do we evaluate the need
 supplemental daily enteral feeding via   for supplemental daily enteral
 a gastrostomy?                           feeding via a gastrostomy?
I. How do we evaluate esophageal         I. How do we evaluate
 stricture or stenosis?.                  esophageal stricture or
                                          stenosis?
J. What do we mean by the phrase         [105.00 C.2., C.4., and G.]
 ``consider under a disability for 1
 year''?
[105.00 C.6.]..........................  J. How do we evaluate your
                                          digestive disorder if there is
                                          no record of ongoing
                                          treatment?
                                         K. How do we evaluate your
                                          digestive disorder if there is
                                          evidence establishing a
                                          substance use disorder?
K. How do we evaluate impairments that   L. How do we evaluate digestive
 do not meet one of the digestive         disorders that do not meet one
 disorder listings?                       of these listings?
------------------------------------------------------------------------
                                Listings
------------------------------------------------------------------------
105.01 Category of Impairments,          105.01 Category of Impairments,
 Digestive System.                        Digestive Disorders
105.02 Gastrointestinal hemorrhaging     105.02 Gastrointestinal
 from any cause, requiring blood          hemorrhaging from any cause,
 transfusion.                             requiring three blood
                                          transfusions
105.03 [Reserved]......................  105.03 [Reserved]
105.04 [Reserved]......................  105.04 [Reserved]
105.05 Chronic liver disease...........  105.05 Chronic liver disease
                                          (CLD)
105.06 Inflammatory bowel disease (IBD)  105.06 Inflammatory bowel
                                          disease (IBD)
105.07 Short bowel syndrome (SBS)......  105.07 Short bowel syndrome
                                          (SBS)
105.08 Growth failure due to any         105.08 Growth failure due to
 digestive disorder.                      any digestive disorder

[[Page 35938]]

 
105.09 Liver transplantation...........  105.09 Liver transplantation
105.10 Need for supplemental daily       105.10 Need for supplemental
 enteral feeding via a gastrostomy.       daily enteral feeding via a
                                          gastrostomy
                                         105.11 Small intestine
                                          transplantation
                                         105.12 Pancreas transplantation
------------------------------------------------------------------------

Skin Disorders Overview of Proposed Revisions
     Adult skin disorders proposed revisions
     Child skin disorders proposed revisions
    The following chart shows the heading of the current and proposed 
sections of the adult introductory text and listings for skin 
disorders:

------------------------------------------------------------------------
     Current sections of the adult        Proposed sections of the adult
 introductory text and listings for the   introductory text and listings
             skin disorders                     for skin disorders
------------------------------------------------------------------------
                         Introductory Text, 8.00
------------------------------------------------------------------------
A. What skin disorders do we evaluate    A. Which skin disorders do we
 with these listings?.                    evaluate under these listings?
B. What documentation do we need?......  B. What are our definitions for
                                          the following terms used in
                                          this body system?
C. How do we assess the severity of      C. What evidence do we need to
 your skin disorder(s)?.                  evaluate your skin disorder?
D. How do we assess impairments that     D. How do we evaluate the
 may affect the skin and other body       severity of skin disorders?
 systems?
E. How do we evaluate genetic            E. How do we evaluate genetic
 photosensitivity disorders?.             photosensitivity disorders
                                          under 8.07?
F. How do we evaluate burns?...........  F. How do we evaluate burns
                                          under 8.08?
G. How do we determine if your skin      G. How do we evaluate chronic
 disorder(s) will continue at a           conditions of the skin or
 disabling level of severity in order     mucous membranes under 8.09?
 to meet the duration requirement?
H. How do we assess your skin            H. How do we evaluate disorders
 disorder(s) if your impairment does      in other body systems that
 not meet the requirements of one of      affect the skin?
 these listings?
I......................................  I. How do we evaluate skin
                                          disorders that do not meet one
                                          of these listings?
------------------------------------------------------------------------
                                Listings
------------------------------------------------------------------------
8.01 Category of Impairments, Skin       8.01 Category of Impairments,
 Disorders.                               Skin Disorders
8.02 Ichthyosis........................  8.02 [Reserved]
8.03 Bullous disease...................  8.03 [Reserved]
8.04 Chronic infections of the skin or   8.04 [Reserved]
 mucous membranes.
8.05 Dermatitis........................  8.05 [Reserved]
8.06 Hidradenitis suppurativa..........  8.06 [Reserved]
8.07 Genetic photosensitivity disorders  8.07 Genetic photosensitivity
                                          disorders
8.08 Burns.............................  8.08 Burns
                                         8.09 Chronic conditions of the
                                          skin or mucous membranes
------------------------------------------------------------------------

    The following chart shows the heading of the current and proposed 
sections of the child introductory text and listings for skin 
disorders:

------------------------------------------------------------------------
     Current sections of the child        Proposed sections of the child
 introductory text and listings for the   introductory text and listings
             skin disorders                     for skin disorders
------------------------------------------------------------------------
                        Introductory Text, 108.00
------------------------------------------------------------------------
A. What skin disorders do we evaluate    A. Which skin disorders do we
 with these listings?.                    evaluate under these listings?
B. What documentation do we need?......  B. What are our definitions for
                                          the following terms used in
                                          this body system?
C. How do we assess the severity of      C. What evidence do we need to
 your skin disorder(s)?.                  evaluate your skin disorder?
D. How do we assess impairments that     D. How do we evaluate the
 may affect the skin and other body       severity of skin disorders?
 systems?
E. How do we evaluate genetic            E. How do we evaluate genetic
 photosensitivity disorders?.             photosensitivity disorders
                                          under 108.07?
F. How do we evaluate burns?...........  F. How do we evaluate burns
                                          under 108.08?
G. How do we determine if your skin      G. How do we evaluate chronic
 disorder(s) will continue at a           conditions of the skin or
 disabling level of severity in order     mucous membranes under 108.09?
 to meet the duration requirement?
H. How do we assess your skin            H. How do we evaluate disorders
 disorder(s) if your impairment does      in other body systems that
 not meet the requirements of one of      affect the skin?
 these listings?
I......................................  I. How do we evaluate skin
                                          disorders that do not meet one
                                          of these listings?
------------------------------------------------------------------------
                                Listings
------------------------------------------------------------------------
108.01 Category of Impairments, Skin     108.01 Category of Impairments,
 Disorders.                               Skin Disorders

[[Page 35939]]

 
108.02 Ichthyosis......................  108.02 [Reserved]
108.03 Bullous disease.................  108.03 [Reserved]
108.04 Chronic infections of the skin    108.04 [Reserved]
 or mucous membranes.
108.05 Dermatitis......................  108.05 [Reserved]
108.06 Hidradenitis suppurativa........  108.06 [Reserved]
108.07 Genetic photosensitivity          108.07 Genetic photosensitivity
 disorders.                               disorders
108.08 Burns...........................  108.08 Burns
                                         108.09 Chronic conditions of
                                          the skin or mucous membranes
------------------------------------------------------------------------

What revisions are we proposing for digestive disorders?

    We propose to:
     Change the name of the body system from ``Digestive 
System'' to ``Digestive Disorders'' to be consistent with the 
nomenclature of all body systems;
     Revise and reorganize the introductory text to provide 
guidance for using the revised criteria in listings;
     Revise the SSA Chronic Liver Disease (SSA CLD) score in 
listings 5.05 and 105.05;
     Add criteria to listings 5.06 and 105.06 for repeated 
complications of IBD;
     Add adult and child listings for small intestine 
transplantation (proposed 5.11 and 105.11) and pancreas transplantation 
(proposed 5.12 and 105.12); and
     Make minor editorial revisions to the introductory text 
and listings for clarity.

Proposed 5.00--Introductory Text to the Adult Digestive Disorders 
Listings

    The following describes changes we are proposing to the 
introductory text.

Proposed 5.00C--What is chronic liver disease (CLD), and how do we 
evaluate it under 5.05?

    We propose to:
     Redesignate current 5.00C (How do we consider the effects 
of treatment?) as proposed 5.00H and remove some of the guidance in 
current 5.00C (paragraphs 1 through C4) because the guidance is a 
restatement of general policy on how we consider the effects of 
treatment that is not unique to digestive disorders but applicable to 
all medically determinable impairments;
     Redesignate current 5.00D (How do we evaluate chronic 
liver disease?) as proposed 5.00C;
     Remove the discussion of hepatitis B and C in current 
5.00D4 (Chronic viral hepatitis infections) because it does not contain 
guidance on evaluating CLD and continue to evaluate CLD resulting from 
hepatitis B and C under proposed listing 5.05;
     In 5.00C2, incorporate the information about CLD 
manifestations that is in current 5.00D3 (Manifestations of chronic 
liver disease) and 5.00D5 through 5.00D10 (Gastrointestinal hemorrhage, 
Ascites or hydrothorax, Spontaneous bacterial peritonitis, Hepatorenal 
syndrome, Hepatopulmonary syndrome, and Hepatic encephalopathy), 
provide guidance on how to assess the severity of these manifestations, 
and include the guidance in current 5.00H (What do we mean by the 
phrase ``consider under a disability for 1 year''?); and
     In 5.00C3, incorporate the information about the SSA CLD 
score calculation in current 5.00D11 (End stage liver disease (ESLD) 
documented by scores from the SSA Chronic Liver Disease (SSA CLD) 
calculation) and add an SSA CLD calculation example.

Proposed 5.00D--What is inflammatory bowel disease (IBD), and how do we 
evaluate it under 5.06?

    We propose to redesignate current 5.00E (How do we evaluate 
inflammatory bowel disease?) as proposed 5.00D. We would describe the 
factors we consider when we evaluate impaired functioning due to IBD 
under proposed 5.06C. We would also define ``marked'' limitation and 
explain the three areas of functioning we use in the proposed listing.

Proposed 5.00E--What is short bowel syndrome (SBS), and how do we 
evaluate it under 5.07?

    We propose to redesignate current 5.00F (How do we evaluate short 
bowel syndrome?) as proposed 5.00E. We would also remove text about 
long-term complications of SBS because this content, while not 
incorrect, is not necessary to understand in order to evaluate SBS 
under 5.07.

Proposed 5.00F--How do we evaluate malnutrition due to any digestive 
disorder under 5.08?

    We propose to redesignate current 5.00G (How do we evaluate weight 
loss due to any digestive disorder?) as proposed 5.00F. We would also 
use the term ``malnutrition'' instead of ``weight loss,'' and clarify 
that weight loss must be the result of malnutrition caused by a 
digestive disorder.

Proposed 5.00G--How do we evaluate digestive organ transplantation?

    We propose to incorporate the guidance in current 5.00D12 (Liver 
transplantation), and the guidance in 5.00H (What do we mean by the 
phrase ``consider under a disability for 1 year''?), in proposed 5.00G.

Proposed 5.00H--How do we evaluate your digestive disorder if there is 
no record of ongoing treatment?

    In proposed 5.00H, we incorporate the guidance in current 5.00C6, 
which explains what we do when there is no record of ongoing treatment. 
As we explained earlier, we removed the guidance in current 5.00C 
(paragraphs 1 through 4) because this the guidance is a restatement of 
general policy on how we consider the effects of treatment that is not 
unique to digestive disorders but applicable to all medically 
determinable impairments.

Proposed 5.00I--How do we evaluate your digestive disorder if there is 
evidence establishing a substance use disorder?

    In proposed 5.00I, we incorporate by reference our regulations for 
determining whether drug addiction or alcoholism is a contributing 
factor material to the determination of disability because use of drugs 
or alcohol may result in a chronic digestive disorder, such as drug-
induced hepatitis or alcoholic liver disease.

Proposed 5.00J--How do we evaluate digestive disorders that do not meet 
one of these listings?

    We propose to redesignate current 5.00I (How do we evaluate 
impairments that do not meet one of the digestive disorder listings?) 
as proposed 5.00J.

Proposed Changes to the Adult Digestive Disorders Listings

Proposed Listing 5.02--Gastrointestinal Hemorrhaging From Any Cause

    We propose to change the period during which the criteria in 
listing 5.02

[[Page 35940]]

must occur from a ``6-month period'' to a ``12-month period'' to be 
consistent with the timeframe criteria in all other body systems within 
the listings.

Proposed Listing 5.05--Chronic Liver Disease (CLD)

    In 5.05A, we propose to clarify the requirement for documenting 
hemodynamic instability by moving the list of signs of hemodynamic 
instability from current 5.00D5 (Gastrointestinal hemorrhage) to 
proposed 5.05A. In 5.05B (Ascites or hydrothorax), we propose to change 
the period during which ascites or hydrothorax must occur from a ``6-
month period'' to a ``12-month period'' to be consistent with the 
timeframe criteria in all other body systems within the listings.
    In 5.05E1 (Hepatopulmonary syndrome documented by arterial PaO2), 
we propose to add ``measured by an ABG test, while at rest, breathing 
room air, less than or equal to'' to clarify our requirements for a 
PaO2 measurement. In 5.05G (SSA CLD scores), we 
propose to change the SSA CLD score requirement from ``22 or greater'' 
to ``at least 20.'' A score of at least 20 accurately identifies 
advanced, end stage liver disease that will prevent a person from 
engaging in any gainful activity or will lead to 
death.4 5 6 7 We also propose to remove the term ``end stage 
liver disease'' because the evidence we require in order for us to 
consider chronic liver disease under 5.05G does not need to include the 
term ``end stage liver disease'' (which may also be referred to as 
``chronic liver failure'').
---------------------------------------------------------------------------

    \4\ Annamalai, A., Harada, M., Chen, M., Tran, T., Ko, A., Ley, 
E., . . . Noureddin, M. (2016). Predictors of mortality in the 
critically ill cirrhotic patient: Is the model for end-stage liver 
disease enough? Journal of the American College of Surgeons, 224(3), 
276-282. doi:10.1016/j.jamcollsurg.2016.11.005.
    \5\ Zhiang, E., Zhang, Z., Want, S., Xiao, Z., Gu, J., Xiong, 
M., . . . Huang, Z. (2016). Predicting the severity of liver 
cirrhosis through clinical parameters. Journal of Surgical Research, 
204(2), 274-281. doi:10.1016/j.jss.2016.04.036.
    \6\ Singal, A.K. & Kamath, P.S. (2013). Model for end-stage 
liver disease. Journal of Clinical and Experimental Hepatology, 
3(1), 50-60. doi:10.1016/j.jceh.2012.11.002.
    \7\ Bittermann, T., Makar, G., & Goldberg, D.S. (2015). Early 
post-transplant survival: Interaction of MELD score and 
hospitalization status. Journal of Hepatology, 63(3), 601-608. 
doi:10.1016/j.jhep.2015.03.034.
---------------------------------------------------------------------------

Proposed Listing 5.06--Inflammatory Bowel Disease (IBD)

    We propose to remove the low hemoglobin, low serum albumin, and 
weight loss criteria, which indicate malnutrition, in current 5.06 
because we will evaluate those criteria under proposed 5.08 
(Malnutrition due to any digestive disorder). In 5.06A (Obstruction of 
stenotic areas) and 5.06B (Combination of clinical findings), we 
propose to change the period during which the listing criteria must 
occur from a ``6-month period'' to a ``12-month period'' to be 
consistent with the timeframe criteria in all other body systems within 
the listings.
    We also propose to add a criterion (proposed 5.06C) for repeated 
complications of IBD that result in marked limitation in at least one 
area of functioning. These criteria characterize complications of IBD 
that prevent a person from engaging in any gainful 
activity.8 9 10 11 This proposed listing combines medical 
criteria with specific limitations in functioning to identify IBD of 
listing-level severity. The addition of functional criteria is also 
consistent with the listings that already include these same functional 
criteria, which are 7.18 (Repeated complications of hematological 
disorders), 14.02B (Repeated manifestations of systemic lupus 
erythematosus), 14.04D (Repeated manifestations of systemic sclerosis), 
14.05E (Repeated manifestations of polymyositis or dermatomyositis), 
14.06B (Repeated manifestations of undifferentiated or mixed connective 
tissue disease), 14.07C (Repeated manifestations of an immune 
deficiency disorder), 14.09D (Repeated manifestations of inflammatory 
arthritis), 14.10B (Sj[ouml]gren's syndrome), and 14.11I (Repeated 
manifestations of HIV infection).
---------------------------------------------------------------------------

    \8\ Farraye, F.A., Melmed, G.Y., Lichtenstein, G.R., & Kane, 
S.V. (2017). ACG clinical guidelines: Preventative care in 
inflammatory bowel disease. American Journal of Gastroenterology, 
112(2), 241-258.
    \9\ Gajendran, M., Loganathan, P., Catinella, A.P., & Hashash, 
J.G. (2018). A comprehensive review and update on Crohn's disease. 
Disease-a-Month, 64, 20-57.
    \10\ Rubin, D.T., Ananthakrishnan, A.N., Siegel, C.A., Sauer, 
B.G., & Long, M.D. (2019). ACG clinical guidelines: Ulcerative 
colitis in adults. American Journal of Gastroenterology, 114(3), 
384-413.
    \11\ Yarur, A.J., Strobel, S.G., Deshpande, A.R., & Abreu, M.T. 
(2011). Predictors of aggressive inflammatory bowel disease. 
Gastroenterology & Hepatology, 7(10), 652-659.
---------------------------------------------------------------------------

Proposed Listing 5.07--Short Bowel Syndrome (SBS)

    We propose to require ``surgical resection of any amount of the 
small intestine'' instead of ``surgical resection of more than one-half 
of the small intestine'' because measurement of the total length of 
remaining intestine within the abdominal cavity is rarely obtained 
during surgery.12 13 14
---------------------------------------------------------------------------

    \12\ Eca, R. & Barbosa, E. (2016). Short bowel syndrome: 
treatment options. Journal of Coloproctology, 36(4), 262-272. 
doi:10.1016/j.jcol.2013.07.002.
    \13\ Hommel, M.J., van Baren, R., & Haveman, J.W. (2016). 
Surgical management and autologous intestinal reconstruction in 
short bowel syndrome. Best Practice & Research Clinical 
Gastroenterology, 30(2), 263-280. doi:10.1016/j.bpg.2016.03.006.
    \14\ Wong, T. & Gupte, G. (2015). Complications of short bowel 
syndrome. Paediatrics and Child Health, 25(9), 418-421. doi:10.1016/
j.paed.2015.07.001.
---------------------------------------------------------------------------

Proposed Listing 5.08--Malnutrition Due to Any Digestive Disorder

    We propose to revise the heading of current 5.08 from ``Weight loss 
due to any digestive disorder'' to ``Malnutrition due to any digestive 
disorder,'' and revise the body mass index (BMI) measurement from 
``less than 17.5'' to ``less than 18.0.'' We also propose to include 
the criteria for low hemoglobin, low serum albumin, and the need for 
supplemental daily enteral or parenteral nutrition, which are in 
current 5.06B. These criteria are findings indicative of malnutrition, 
which may result from any digestive disorder, not just IBD. The 
combination of low BMI measurements and one of these other findings 
improves the specificity of listing 5.08.\15\ Lastly, we propose to 
change the period during which the listing criteria must occur from a 
``6-month period'' to a ``12-month period'' to be consistent with the 
timeframe criteria in all other body systems within the listings.
---------------------------------------------------------------------------

    \15\ Naldi, M., Baldassarre, M., Domenicali, M., Bartolini, M., 
& Caraceni, P. (2017). Structural and functional integrity of human 
serum albumin: Analytical approaches and clinical relevance in 
patients with liver cirrhosis. Journal of Pharmaceutical and 
Biomedical Analysis, 144, 138-153. doi.org/10.1016/j.jpba.2017.04.023.
---------------------------------------------------------------------------

Proposed Digestive Organ Transplantation Listings

    We propose to add listing 5.11 for small intestine transplantation 
and listing 5.12 for pancreas transplantation.16 17 We 
currently evaluate small intestine and pancreas transplantations under 
listing 5.09 for liver transplantation using our medical equivalence 
rules. The separate listings would allow us to differentiate which 
digestive organ has been transplanted and allow us to propose future 
updates to each separate listing, as needed, based on medical advances 
in the specific organ transplant category.
---------------------------------------------------------------------------

    \16\ Dholakia, S., Mittal, S., Quiroga, I., Gilbert, J., 
Sharples, E.J., Ploeg, R.J., & Friend, P.J. (2016). Pancreas 
transplantation: Past, present, future. The American Journal of 
Medicine, 129(7), 667-673. doi:10.1016/j.amjmed.2016.02.011.
    \17\ Hommel, M.J., van Baren, R., & Haveman, J.W. (2016). 
Surgical management and autologous intestinal reconstruction in 
short bowel syndrome. Best Practice & Research Clinical 
Gastroenterology, 30(2), 263-280. doi:10.1016/j.bpg.2016.03.006.

---------------------------------------------------------------------------

[[Page 35941]]

Proposed 105.00--Introductory Text to the Child Digestive Disorders 
Listings

    We repeat much of the introductory text of proposed 5.00 in the 
introductory text of proposed 105.00. This repetition is because the 
same basic rules apply for evaluating digestive disorders in adults and 
in children.

Proposed Changes to the Child Digestive Disorders Listings

    We are proposing changes in the child listings to correspond with 
the changes we are proposing in the adult listings. The reasons we gave 
earlier for changing or removing current criteria for adults also apply 
to the criteria for children. Additionally, the numbering of the child 
listings would conform to the adult listings.

What revisions are we proposing for skin disorders?

    We propose to:
     Revise and reorganize the introductory text to provide 
guidance for using the revised criteria in listings;
     Remove and reserve current adult listings 8.02 
(Ichthyosis), 8.03 (Bullous disease), 8.04 (Chronic infections of the 
skin or mucous membranes), 8.05 (Dermatitis), and 8.06 (Hidradenitis 
suppurativa) and consolidate the current criteria into one listing for 
chronic conditions of the skin or mucous membranes (proposed 8.09), and 
remove and reserve current child listings 108.02 (Ichthyosis), 108.03 
(Bullous disease), 108.04 (Chronic infections of the skin or mucous 
membranes), 108.05 (Dermatitis), and 108.06 (Hidradenitis suppurativa) 
and consolidate the current criteria into one listing for chronic 
conditions of the skin or mucous membranes (proposed 108.09), to 
strengthen adjudicative ease and more efficiently capture adults and 
children with skin disorders of listing-level severity;
     Include limitations of physical functioning we use to 
assess impairment severity, which are explained in current 8.00C and 
108.00C (How do we assess the severity of your skin disorder(s)?), in 
the listing criteria for adult listings 8.07B (Other genetic 
photosensitivity disorders), 8.08 (Burns), and 8.09 (Chronic conditions 
of the skin or mucous membranes) and child listings 108.07B (Other 
genetic photosensitivity disorders), 108.08 (Burns), and 108.09 
(Chronic conditions of the skin or mucous membranes); and
     Make minor editorial revisions to the introductory text 
and listings for clarity.

Proposed 8.00--Introductory Text to the Adult Skin Disorders Listings

    Most of the guidance in the proposed introductory text is 
substantively the same as the guidance in the current introductory 
text. The following is a detailed description of the significant 
changes we are proposing to the introductory text. In addition to the 
changes we describe below, we are proposing other, minor changes to the 
introductory text to clarify how we use the proposed listings to 
evaluate skin disorders.

Proposed 8.00B--What are our definitions for the following terms used 
in this body system?

    In this new section, 8.00B, we provide definitions for terms, such 
as ``chronic skin lesions'' and ``contractures,'' that we use in the 
listings to evaluate skin disorders.

Proposed 8.00C--What evidence do we need to evaluate your skin 
disorder?

    In 8.00C, we incorporate the guidance in current 8.00B (What 
documentation do we need?).

Proposed 8.00D--How do we evaluate the severity of skin disorders?

    In 8.00D, we discuss how we evaluate the severity of skin disorders 
(which is now contained in current 8.00C) and add a clearer explanation 
for how we quantify limitations in functioning under these listings. In 
8.00D1, we explain how we evaluate the severity of skin disorders based 
on the site(s) of the lesions or contractures and the response to 
treatment. In 8.00D2, we explain the functional criteria we use to 
evaluate skin disorders under proposed 8.07B (Other genetic 
photosensitivity disorders), 8.08 (Burns), and 8.09 (Chronic conditions 
of the skin or mucous membranes). Chronic skin lesions or contractures 
may restrict movement and result in limitation(s) of physical 
functioning (ability to use the upper extremities, stand up from a 
seated position, or maintain an upright position while standing or 
walking). In 8.00D3, we propose to replace the term ``flare-ups'' with 
``exacerbations.''
    In 8.00D4, we propose to incorporate the guidance on symptoms in 
current 8.00C3 (Symptoms (including pain)). In 8.00D5, we propose to 
incorporate and revise the guidance on treatment in current 8.00D4 
(Disfigurement or deformity) and 8.00G (How do we determine if your 
skin disorder(s) will continue at a disabling level of severity in 
order to meet the duration requirement?). We propose to replace the 
term ``continuing treatment as prescribed'' with ``adherence to 
prescribed medical treatment'' to be consistent with current medical 
terminology. In 8.00D5b, we provide guidance on how to evaluate skin 
disorders after adherence to prescribed medical treatment for 3 months.
    In 8.00D5c, we provide guidance on how to evaluate claims in which 
the prescribed medical treatment is psoralen and ultraviolet A light 
(PUVA) or biologics. PUVA is a treatment involving exposure to UVA 
light after taking a biologic medication called psoralen that increases 
the skin's sensitivity to ultraviolet light. PUVA is generally used 
under medical supervision when other conservative treatments for skin 
disorders have proven to be ineffective.18 19 20 21 We 
explain that, if a person receives PUVA or biologics, we will defer 
adjudication until 6 months from the start of treatment unless we can 
make a fully favorable determination or decision on another basis. In 
8.00D6, we clarify how we evaluate cases in which there is no 
longitudinal record of ongoing treatment.
---------------------------------------------------------------------------

    \18\ Farahnik, B., Nakamura, M., Singh, R.K., Abrouk, M., Zhu, 
T.H., Lee, K.M., . . . Liao, W. (2016). The patient's guide to 
psoriasis treatment. Part 2: PUVA phototherapy. Dermatology and 
Therapy, 6(3), 315-324. doi:10.1007/s13555-016-0130-9.
    \19\ Ong, S., & Venning, V. (2014). PUVA treatment information 
for patients. Retrieved from Oxford University Hospital NHS website: 
https://www.ouh.nhs.uk/patient-guide/leaflets/files/120719puva.pdf.
    \20\ Shenoi, S.D., & Prabhu, S. (2014). Photochemotherapy (PUVA) 
in psoriasis and vitiligo. Indian Journal of Dermatology, 
Venereology and Leprology, 80(6), 497-504. doi:10.4103/0378-
6323.144143.
    \21\ Weber, F., Schmuth, M., Seep, N., & Fritsch, P. (2005). 
Bath-water PUVA therapy with 8-methoxypsoralen in mycosis fungoides. 
Acta Dermato-Venereologica, 85, 329-332. doi:10.1080/
00015550510032814.
---------------------------------------------------------------------------

Proposed 8.00E--How do we evaluate genetic photosensitivity disorders 
under 8.07?

    In 8.00E3, we explain that we will not purchase genetic testing, 
but will consider the results of this testing if it is in a person's 
case record. In 8.00E4, we include what the phrase ``inability to 
function outside of a highly protective environment'' means, which is 
in current 8.00E2 (Other genetic photosensitivity disorders).

Proposed 8.00F--How do we evaluate burns under 8.08?

    In 8.00F, we include guidance for evaluating third-degree burns 
resulting in contractures that have been documented by an acceptable 
medical source to have reached maximum therapeutic benefit.

[[Page 35942]]

Proposed 8.00G--How do we evaluate chronic conditions of the skin or 
mucous membranes under 8.09?

    In 8.00G, we provide examples of the skin disorders we evaluate 
under new listing 8.09, which include ichthyosis, bullous diseases, 
chronic skin infections, dermatitis, and hidradenitis suppurativa.

Proposed 8.00H--How do we evaluate disorders in other body systems that 
affect the skin?

    In 8.00H, we include the guidance in current 8.00D (How do we 
assess impairments that may affect the skin and other body systems?). 
We also propose to include a new paragraph (8.00H1) on evaluating skin 
disorders that are complications of diabetes mellitus.

Proposed 8.00I--How do we evaluate skin disorders that do not meet one 
of these listings?

    In 8.00I, we include the guidance in current 8.00H (How do we 
assess your skin disorder(s) if your impairment does not meet the 
requirements of one of these listings?).

Proposed Changes to the Adult Skin Disorders Listings

Proposed Listing 8.07--Genetic Photosensitivity Disorders

    We propose to include the functional criteria, which we explain 
above, directly in 8.07B to evaluate limitation of physical functioning 
due to a genetic photosensitivity disorder. In some cases, this 
requirement may be overlooked by adjudicators because the functional 
criteria are not currently included as listing criteria, but rather are 
explained in the introductory text.

Proposed Listing 8.08--Burns

    We propose to include the functional criteria, which we explain 
above, directly in 8.08 to evaluate limitation of physical functioning 
due to burns. In some cases, this requirement may be overlooked by 
adjudicators because the functional criteria are not currently included 
as listing criteria, but rather are explained in the introductory text.

Proposed Listing 8.09--Chronic Conditions of the Skin or Mucous 
Membranes

    We propose to remove and reserve current listings 8.02 
(Ichthyosis), 8.03 (Bullous disease), 8.04 (Chronic infections of the 
skin or mucous membranes), 8.05 (Dermatitis), and 8.06 (Hidradenitis 
suppurativa) and add listing 8.09 to evaluate these skin disorders. The 
criteria in the current listings are identical for each type of skin 
disorder, and all of the named disorders are chronic conditions of the 
skin or mucous membranes. In proposed 8.09, we propose to include the 
functional criteria, which we explain above, to evaluate limitation in 
physical functioning due to these skin disorders. In some cases, this 
requirement may be overlooked by adjudicators because the functional 
criteria are not currently included as listing criteria, but rather are 
explained in the introductory text.

Proposed 108.00--Introductory Text to the Child Skin Disorders Listings

    We repeat much of the introductory text of proposed 8.00 in the 
introductory text of proposed 108.00. This repetition is because the 
same basic rules apply for evaluating skin disorders in adults also 
apply to skin disorders in children with one exception--how we evaluate 
limitation of physical functioning. Children's physical abilities 
change as they grow and mature. For example, young infants are not able 
to walk, but do move their extremities and may use them to roll over, 
crawl, or perform other functions as they develop. To evaluate the 
severity of skin disorders in children, we propose to use criteria 
based on a child's ability to independently initiate, sustain, and 
complete age-appropriate activities.

Proposed Changes to the Child Skin Disorders Listings

    We are proposing changes in the child listings to correspond with 
the changes we are proposing in the adult listings. Other changes are 
specific to how we evaluate skin disorders in children. The reasons we 
gave earlier for changing or removing current criteria for adults also 
apply to the criteria for children. Additionally, the numbering of the 
child listings would conform to that of the adult listings.

Other Questions

    We are interested in receiving public comments on the following 
topics:
     Are there any digestive or skin disorders that meet one of 
the proposed listings, but are generally expected to medically improve 
after a certain amount of time to the point at which the disorders are 
no longer of listing-level severity? If you believe there are digestive 
or skin disorders that fit into this category, please tell us by 
submitting your comments and any supporting research or data on that 
issue.
     Do the proposed rules for evaluating chronic conditions of 
the skin or mucous membranes (conditions such as psoriasis and 
hidradenitis suppurativa) appropriately consider whether treatment 
regimens interfere with the ability to do any work? If you believe the 
criteria should be revised, please tell us by submitting your comments 
and any supporting research or data.
     Should any of the proposed listings for either digestive 
disorders or skin disorders be combined into one listing or divided 
into multiple listings to strengthen adjudicative ease and capture 
adults or children with impairments that are of listing-level severity?
     Based on advances in medical functional restorative 
treatment of many skin disorders, is our proposal for the durations of 
persistent treatment appropriate for listing-level severity? 
Specifically, the current listings for chronic skin infections require 
that claimants be considered for listing-level severity if 
exacerbations persist despite adherence to prescribed medical treatment 
for three months, unless we can make a fully favorable determination or 
decision on another basis. We propose that, for claimants who have 
access to treatment with PUVA or biologics, the skin disorder be 
considered for listing-level severity if exacerbations persist despite 
treatment for six months from the start of PUVA or biologics. 
Alternatively, for burns, we propose that, for consideration of 
listing-level severity, an acceptable medical source document maximum 
therapeutic benefit and, therefore, a claimant is no longer receiving 
surgical management. Do these criteria create incentive to not seek 
medical treatment in order to obtain or maintain access to disability 
benefits? If you believe the criteria for skin disorder treatment 
duration should be revised, please tell us by submitting your comments 
and any supporting research or data.

What is our authority to make rules and set procedures for determining 
whether a person is disabled under the statutory definition?

    The Act authorizes us to make rules and regulations and to 
establish necessary and appropriate procedures to implement them.\22\
---------------------------------------------------------------------------

    \22\ Sections 205(a), 702(a)(5), and 1631(d)(1).
---------------------------------------------------------------------------

How long would these proposed rules be effective?

    If we publish these proposed rules as final rules, they will remain 
in effect for 5 years after the date they become effective, unless we 
extend them, or revise and issue them again.

[[Page 35943]]

Rulemaking Analyses and Notices

    We will consider all comments we receive on or before the close of 
business on the comment closing date indicated above. The comments will 
be available for examination in the rulemaking docket for these rules 
at the above address. We will file comments received after the comment 
closing date in the docket and will consider those comments to the 
extent practicable. However, we will not respond specifically to 
untimely comments. We may publish a final rule at any time after close 
of the comment period.

Clarity of These Proposed Rules

    Executive Order 12866, as supplemented by Executive Order 13563, 
requires each agency to write all rules in plain language. In addition 
to your substantive comments on these proposed rules, we invite your 
comments on how to make them easier to understand.
    For example:
     Would more, but shorter, sections be better?
     Are the requirements in the rules clearly stated?
     Have we organized the material to suit your needs?
     Could we improve clarity by adding tables, lists, or 
diagrams?
     What else could we do to make the rules easier to 
understand?
     Do the rules contain technical language or jargon that is 
not clear?
     Would a different format make the rules easier to 
understand; e.g., grouping and order of sections, use of headings, 
paragraphing?

When will we start to use these rules?

    We will not use these proposed rules until we evaluate public 
comments and publish final rules in the Federal Register. All final 
rules we issue include an effective date. We will continue to use our 
current rules until that date. If we publish final rules, we will 
include a summary of the relevant comments we received and an 
explanation of how we will apply the new rules.

Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

    We consulted with the Office of Management and Budget (OMB) and 
determined that these proposed rules meet the criteria for a 
significant regulatory action under Executive Order 12866, as 
supplemented by Executive Order 13563. Therefore, OMB reviewed them.
    We also determined that these proposed rules meet the plain 
language requirement of Executive Order 12866.

Executive Order 13132 (Federalism)

    We analyzed these proposed rules in accordance with the principles 
and criteria established by Executive Order 13132, and determined that 
these proposed rules will not have sufficient Federalism implications 
to warrant the preparation of a Federalism assessment. We also 
determined that these proposed rules will not preempt any State law or 
State regulation or affect the States' abilities to discharge 
traditional State governmental functions.

Regulatory Flexibility Act

    We certify that these proposed rules would not have a significant 
economic impact on a substantial number of small entities because they 
affect individuals only. Therefore, a regulatory flexibility analysis 
is not required under the Regulatory Flexibility Act, as amended.

Executive Order 13771

Anticipated Accounting Costs of These Proposed Rules

Anticipated Costs to Our Programs
    Our Office of the Chief Actuary estimates, based on the best 
available data, that this proposed rule, assuming it is finalized and 
implemented for all disability decisions completed after February 1, 
2020, would result in a reduction of $155 million in OASDI benefit 
payments and a reduction of $55 million in Federal SSI payments over 
the 10-year period of FY 2019-2028.
Anticipated Administrative Costs to the Social Security Administration
    The Office of Budget, Finance, and Management estimated 
administrative savings of less than 15 work years and $2 million 
annually, which we consider to be a non-significant amount.

Paperwork Reduction Act

    These rules do not create any new or affect any existing 
collections and, therefore, do not require OMB approval under the 
Paperwork Reduction Act.

References

    We consulted the following references when we developed these 
proposed rules:

Digestive Disorders

Annamalai, A., Harada, M., Chen, M., Tran, T., Ko, A., Ley, E., . . 
. Noureddin, M. (2016). Predictors of mortality in the critically 
ill cirrhotic patient: Is the model for end-stage liver disease 
enough? Journal of the American College of Surgeons, 224(3), 276-
282. doi:10.1016/j.jamcollsurg.2016.11.005.
Bajaj, J.S., O'Leary, J.G., Tandon, P., Wong, F., Garcia-Tsao, G., 
Kamath, P.S., . . . Reddy, K.R. (2017). Hepatic encephalopathy is 
associated with mortality in patients with cirrhosis independent of 
other extrahepatic organ failures. Clinical Gastroenterology and 
Hepatology, 15(4), 565-574. doi:10.1016/j.cgh.2016.09.157.
Bhutta, A.Q. & Garcia-Tsao, G. (2015). The role of medical therapy 
for variceal bleeding. Gastrointestinal Endoscopy Clinics of North 
America, 25(3), 479-490. doi:10.1016/j.giec.2015.03.001.
Brown, C.L., Hammill, B.G., Qualls, L.G., Curtis, L.H., & Muir, A.J. 
(2016). Significant morbidity and mortality among hospitalized end-
stage liver disease patients in Medicare. Journal of Pain and 
Symptom Management, 52(3), 412-419. doi:10.1016/
j.jpainsymman.2016.03.013.
Farraye, F.A., Melmed, G.Y., Lichtenstein, G.R., & Kane, S.V. 
(2017). ACG clinical guidelines: Preventative care in inflammatory 
bowel disease. American Journal of Gastroenterology, 112(2), 241-
258.
Gajendran, M., Loganathan, P., Catinella, A.P., & Hashash, J.G. 
(2018). A comprehensive review and update on Crohn's disease. 
Disease-a-Month, 64, 20-57.
Garcia-Tsao, G. & Bosch, J. (2015). Varices and variceal hemorrhage 
in cirrhosis: A new view of an old problem. Clinical 
Gastroenterology and Hepatology, 13(12), 2109-2117. doi:10.1016/
j.cgh.2015.07.012.
Jalan, R., Gines, P., Olson, J.C., Mookerjee, R.P., Moreau, R., 
Garcia-Tsao, G., . . . Kamath, P.S. (2012). Acute-on chronic liver 
failure. Journal of Hepatology, 57(6), 1336-1348. doi:10.1016/
j.jhep.2012.06.026.
Kandiah, P.A. & Kumar, G. (2016). Hepatic encephalopathy--the old 
and the new. Critical Care Clinics, 32(3), 311-329. doi:10.1016/
j.ccc.2016.03.001.
Kim, K., Han, B.J., Yang, S., Na, S.Y., Park, S., Boo, S., . . . 
Kim, J. (2012). Risk factors and outcome of acute severe lower 
gastrointestinal bleeding in Crohn's disease. Digestive and Liver 
Disease, 44(9), 723-728. doi:10.1016/j.dld.2012.03.010.
Lafferty, H.D., & Morris, J. (2015). Acute upper gastrointestinal 
haemorrhage. Medicine, 43(3), 161-166. doi:10.1016/
j.mpmed.2014.12.003.
Macken, L. & Blaker, P.A. (2015). Management of acute severe 
ulcerative colitis (NICE CG 166). Clinical Medicine, 15(5), 473-476. 
doi.org/10.7861/clinmedicine.15-5-473.
Moore, K. (2015). Diagnosis and management of ascites and 
hepatorenal syndrome (acute kidney injury) in cirrhosis. Medicine, 
43(11), 674-678. doi:10.1016/j.mpmed.2015.08.004.
Muir, A.J. (2015). Understanding the complexities of cirrhosis. 
Clinical Therapeutics, 37(8), 1822-1836. doi:10.1016/
j.clinthera.2015.05.507.
Naldi, M., Baldassarre, M., Domenicali, M., Bartolini, M., & 
Caraceni, P. (2017).

[[Page 35944]]

Structural and functional integrity of human serum albumin: 
Analytical approaches and clinical relevance in patients with liver 
cirrhosis. Journal of Pharmaceutical and Biomedical Analysis, 144, 
138-153. doi:10.1016/j.jpba.2017.04.023.
National Academies of Sciences, Engineering, and Medicine. (2018). 
Health-care utilization as a proxy in disability determination. 
Washington, DC: The National Academies Press. doi:10.17226/24969.
Nevah, M.I. & Fallon, M. (2010). Hepatic encephalopathy, hepatorenal 
syndrome, hepatopulmonary syndrome, and systematic complications of 
liver disease. In M. Feldman, L.S. Friedman, & L.J. Brandt (Eds.), 
Sleisenger and Fordtran's gastrointestinal and liver disease, (pp. 
1543-1554). Philadelphia, PA: Saunders Elsevier.
Nolan, J.D., Johnston, I.M., & Walters, J.R. (2015). Physiology of 
malabsorption. Surgery (Oxford), 55(5), 193-199. doi:10.1016/
j.mpsur.2015.02.003.
Peyrin-Biroulet, L., Pan[eacute]s, J., Sandborn, W.J., Vermeire, S., 
Danese, S., Feagan, B.G., . . . Rycroft, B. (2016). Defining disease 
severity in inflammatory bowel diseases: Current and future 
directions. Clinical Gastroenterology and Hepatology, 14(3), 348-
354. doi:10.1016/j.cgh.2015.06.001.
Rubin, D.T., Ananthakrishnan, A.N., Siegel, C.A., Sauer, B.G., & 
Long, M.D. (2019). ACG clinical guidelines: Ulcerative colitis in 
adults. American Journal of Gastroenterology, 114(3), 384-413.
Shokoohi, H., Pourmand, A., Teng, J., & Lucas, J. (2017). Acute 
liver failure and emergency consideration for liver transplant. The 
American Journal of Emergency Medicine, 35(11), 1779-1781. 
doi:10.1016/j.ajem.2017.05.028.
Singal, A.K. & Kamath, P.S. (2013). Model for end-stage liver 
disease. Journal of Clinical and Experimental Hepatology, 3(1), 50-
60. doi:10.1016/j.jceh.2012.11.002.
Tee, C.T., Wallis, K., & Gabe, S.M. (2011). Emerging treatment 
options for short bowel syndrome: Potential role of teduglutide. 
Clinical and Experimental Gastroenterology, 4, 189-196. doi:10.2147/
CEG.S13906.
Vuachet, D., Cervoni, J., Vuitton, L., Weil, D., Dritsas, S., 
Dussaucy, A., . . . Thevenot, T. (2015). Improved survival of 
cirrhotic patients with variceal bleeding over the decade 2000-2010. 
Clinics and Research in Hepatology and Gastroenterology, 39(1), 59-
67. doi:10.1016/j.clinre.2014.06.018.
Wei, Q., Nemdarry, R.S., Zhuang, R., Li, J., Ling, Q., Wu, J., . . . 
Zheng, S. (2017). A good prognostic predictor for liver 
transplantation recipients with benign end-stage liver cirrhosis. 
Hepatobiliary & Pancreatic Diseases International, 16(2), 164-168. 
doi:10.1016/S1499-3872(16)60187-X.
Yarur, A.J., Strobel, S.G., Deshpande, A.R., & Abreu, M.T. (2011). 
Predictors of aggressive inflammatory bowel disease. 
Gastroenterology & Hepatology, 7(10), 652-659.
Zhiang, E., Zhang, Z., Want, S., Xiao, Z., Gu, J., Xiong, M., . . . 
Huang, Z. (2016). Predicting the severity of liver cirrhosis through 
clinical parameters. Journal of Surgical Research, 204(2), 274-281. 
doi:10.1016/j.jss.2016.04.036.

Skin Disorders

De Jager, M.E., de Jong, E.M., van de Kerkhof, P.C., & Seyger M.M. 
(2010). Efficacy and safety of treatments for childhood psoriasis: A 
systematic literature review. Journal of the American Academy of 
Dermatology, 62(6), 1013-1030. doi:10.1016/j.jaad.2009.06.048.
DiGiovanna, J.J., & Kraemer, K.H. (2012). Shining a light on 
xeroderma pigmentosum. Journal of Investigative Dermatology, 132(3), 
785-796. doi:10.1038/jid.2011.426.
Eichenfield, L.F., Tom, W.L., Berger, T.G., Krol, A., Paller, A.S., 
Schwarzenberger, K., . . . Sidbury, R. (2014). Guidelines of care 
for management of atopic dermatitis: Section 2. Management and 
treatment of atopic dermatitis with topical therapies. Journal of 
the American Academy of Dermatology, 71(1), 116-132. doi:10.1016/
j.jaad.2014.03.023.
Farahnik, B., Nakamura, M., Singh, R.K., Abrouk, M., Zhu, T.H., Lee, 
K.M., . . . Liao, W. (2016). The patient's guide to psoriasis 
treatment. Part 2: PUVA phototherapy. Dermatology and Therapy, 6(3), 
315-324. doi:10.1007/s13555-016-0130-9.
Gupta, R., Woodley, D.T., & Chen, M. (2012). Epidermolysis bullosa 
acquisita. Clinics in Dermatology, 30(1), 60-69. doi:10.1016/
j.clindermatol.2011.03.011.
Jemec, G.B., & Kimball, A.B. (2015). Hidradenitis suppurativa: 
Epidemiology and scope of the problem. Journal of the American 
Academy of Dermatology, 73(5), S4-S7. doi:10.1016/
j.jaad.2015.07.052.
Ong, S., & Venning, V. (2014). PUVA treatment information for 
patients. Retrieved from Oxford University Hospital NHS website: 
https://www.ouh.nhs.uk/patient-guide/leaflets/files/120719puva.pdf.
Prens, E., & Deckers, I. (2015). Pathophysiology of hidradenitis 
suppurativa: An update. Journal of the American Academy of 
Dermatology, 73(5), S8-S11. doi:10.1016/j.jaad.2015.07.045.
Rachakonda, T.D., Schupp, C.W., & Armstrong, A.W. (2014). Psoriasis 
prevalence among adults in the United States. Journal of the 
American Academy of Dermatology, 70(3), 512-516. doi:10.1016/
j.jaad.2013.11.013.
Rich-Garg, N., Truong, B., Ehst, B., Deodhar, A., Ku, J., Vakil-
Gilani, K., . . . Blauvelt, A. (2015). Demographics, clinical 
disease characteristics, and quality of life in a large cohort of 
psoriasis patients with and without psoriatic arthritis. Clinical, 
Cosmetic and Investigational Dermatology, 8, 563-569. doi:10.2147/
ccid.s90270.
Schwieger-Briel, A., Moellmann, C., Mattulat, B., Schauer, F., 
Kiritsi, D., Schmidt, E., . . . Kern, J.S. (2014). Bullous 
pemphigoid in infants: characteristics, diagnosis and treatment. 
Orphanet Journal of Rare Diseases, 9, 185. doi:10.1186/s13023-014-
0185-6.
Shenoi, S.D., & Prabhu, S. (2014). Photochemotherapy (PUVA) in 
psoriasis and vitiligo. Indian Journal of Dermatology, Venereology 
and Leprology, 80(6), 497-504. doi:10.4103/0378-6323.144143.
Sidbury, R., Tom, W.L., Bergman, J.N., Cooper, K.D., Silverman, 
R.A., Berger, T.G., . . .Eichenfield, L.F. (2014). Guidelines of 
care for the management of atopic dermatitis: Section 4. Prevention 
of disease flares and use of adjunctive therapies and approaches. 
Journal of the American Academy of Dermatology, 71(6), 1218-1233. 
doi:10.1016/j.jaad.2014.08.038.
Tollefson, M.M., Crowson, C.S., McEvoy, M.T., & Kremers, H.M. 
(2010). Incidence of psoriasis in children: A population-based 
study. Journal of the American Academy of Dermatology, 62(6), 979-
987. doi:10.1016/j.jaad.2009.07.029.
van der Zee, H.H., & Jemec, G.B. (2015). New insights into the 
diagnosis of hidradenitis suppurativa: Clinical presentations and 
phenotypes. Journal of the American Academy of Dermatology, 73(5), 
23-26. doi:10.1016/j.jaad.2015.07.047.
Watson, W. & Kapur, S. (2011). Atopic dermatitis. Allergy, Asthma & 
Clinical Immunology, 7(1), 1-7. doi:10.1186/1710-1492-7-S1-S4.
Weber, F., Schmuth, M., Seep, N., & Fritsch, P. (2005). Bath-water 
PUVA therapy with 8-methoxypsoralen in mycosis fungoides. Acta 
Dermato-Venereologica, 85, 329-332. doi:10.1080/00015550510032814.

    We will make these references available to you for inspection if 
you are interested in reading them. Please make arrangements with 
the contact person shown in this preamble if you would like to 
review any reference materials.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security--Disability Insurance; 96.002, Social Security--Retirement 
Insurance; 96.004, Social Security--Survivors Insurance; and 96.006, 
Supplemental Security Income).

List of Subjects in 20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, 
Old-age, survivors, and disability insurance, Reporting and 
recordkeeping requirements, Social Security.

Andrew Saul,
Commissioner of Social Security.

    For the reasons set forth in the preamble, we propose to amend 
subpart P of part 404 of title 20 of the Code of Federal Regulations as 
set forth below:

[[Page 35945]]

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950- )

Subpart P--Determining Disability and Blindness

0
1. The authority citation for subpart P of part 404 continues to read 
as follows:

    Authority: Secs. 202, 205(a), (b), and (d)-(h), 216(i), 221(a) 
and (h)-(j), 222(c), 223, 225, and 702(a)(5) of the Social Security 
Act (42 U.S.C. 402, 405(a), (b), and (d)-(h), 416(i), 421(a) and 
(h)-(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-
193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 
(42 U.S.C. 902 note).

0
2. Amend appendix 1 to subpart P of part 404 as follows:
0
a. Revise items 6 and 9 of the introductory text before part A;
0
b. In part A, revise the body system name for section 5.00 in the table 
of contents and sections 5.00 and 8.00; and
0
c. In part B, revise the body system name for section 105.00 in the 
table of contents and sections 105.00 and 108.00.
    The revisions read as follows:

Appendix 1 to Subpart P of Part 404--Listing of Impairments

* * * * *
    6. Digestive Disorders (5.00 and 105.00) [date 5 years from the 
effective date of the final rule].
* * * * *
    9. Skin Disorders (8.00 and 108.00) [date 5 years from the 
effective date of the final rule].
* * * * *

Part A

* * * * *

5.00 Digestive Disorders

* * * * *

5.00 Digestive Disorders

    A. Which digestive disorders do we evaluate in this body system? 
We evaluate digestive disorders that result in severe dysfunction of 
the liver, pancreas, and gastrointestinal tract (the large, muscular 
tube that extends from the mouth to the anus, where the movement of 
muscles, along with the release of hormones and enzymes, allows for 
the digestion of food) in this body system. Examples of such 
disorders and the listings we use to evaluate them include chronic 
liver disease (5.05), inflammatory bowel disease (5.06), and short 
bowel syndrome (5.07). We also use this body system to evaluate 
gastrointestinal hemorrhaging from any cause (5.02), malnutrition 
due to any digestive disorder (5.08), liver transplantation (5.09), 
small intestine transplantation (5.11), and pancreas transplantation 
(5.12). We evaluate cancers affecting the digestive system under the 
listings in 13.00.
    B. What evidence do we need to evaluate your digestive disorder?
    1. General. To establish that you have a digestive disorder, we 
need medical evidence about the existence of your digestive disorder 
and its severity. Medical evidence should include your medical 
history, physical examination findings, operative reports, and 
relevant laboratory findings.
    2. Laboratory findings. We need laboratory reports such as 
results of imaging (see 5.00B3), endoscopy, and other diagnostic 
procedures. We may also need clinical laboratory and pathology 
results.
    3. Imaging refers to medical imaging techniques, such as x-ray, 
ultrasound, magnetic resonance imaging, and computerized tomography. 
The imaging must be consistent with the prevailing state of medical 
knowledge and clinical practice as a proper technique to support the 
evaluation of the disorder.
    C. What is chronic liver disease (CLD), and how do we evaluate 
it under 5.05?
    1. General. CLD is loss of liver function with cell necrosis 
(cell death), inflammation, or scarring of the liver that persists 
for more than 6 months. Common causes of CLD in adults include 
chronic infection with hepatitis B virus (HBV) or hepatitis C virus 
(HCV), and prolonged alcohol abuse.
    a. We will evaluate your signs of CLD, such as jaundice, changes 
in size of the liver and spleen, ascites, peripheral edema, or 
altered mental status. We will also evaluate your symptoms of CLD, 
such as pruritus (itching), fatigue, nausea, loss of appetite, or 
sleep disturbances when we assess the severity of your impairment(s) 
and how it affects your ability to function. In the absence of 
evidence of a chronic liver impairment, episodes of acute liver 
disease do not meet the requirements of 5.05.
    b. Laboratory findings of your CLD may include decreased serum 
albumin, increased International Normalized Ratio (INR), arterial 
deoxygenation (hypoxemia), increased serum creatinine, oliguria 
(reduced urine output), or sodium retention. Another laboratory 
finding that may be included in the evidence is a liver biopsy. If 
you have had a liver biopsy, we will make every reasonable effort to 
obtain the results; however, we will not purchase a liver biopsy.
    2. Manifestations of CLD.
    a. Gastrointestinal hemorrhaging (5.05A), as a consequence of 
cirrhosis and high pressure in the liver's portal venous system, may 
occur from varices (dilated veins in the esophagus or the stomach) 
or from portal hypertensive gastropathy (abnormal mucosal changes in 
the stomach). When gastrointestinal hemorrhaging is due to a cause 
other than CLD, we evaluate it under 5.02. The phrase ``consider 
under a disability for 1 year'' in 5.02 and 5.05A does not refer to 
the date on which your disability began, only to the date on which 
we must reevaluate whether your impairment(s) continues to meet a 
listing or is otherwise disabling. We determine the onset of your 
disability based on the facts of your case.
    b. Ascites or hydrothorax (5.05B) is a pathologic accumulation 
of fluid in the peritoneal cavity (ascites) or pleural space 
(hydrothorax). Ascites or hydrothorax may be diagnosed by removing 
some of the fluid with needle aspiration (paracentesis or 
thoracentesis), physical examination, or imaging. The most common 
causes of ascites are portal hypertension and low serum albumin 
resulting from CLD. We evaluate other causes of ascites and 
hydrothorax that are unrelated to CLD, such as congestive heart 
failure and cancer, under the listings in the affected body systems.
    c. Spontaneous bacterial peritonitis (SBP) (5.05C) is an acute 
bacterial infection of peritoneal fluid, and is most commonly 
associated with CLD. SBP is diagnosed by laboratory analysis of 
peritoneal fluid (obtained by paracentesis) that contains a 
neutrophil count (also called absolute neutrophil count) of at least 
250 cells/mm\3\. 5.05C is satisfied with one evaluation documenting 
peritoneal infection. We evaluate other causes of peritonitis that 
are unrelated to CLD, such as tuberculosis, malignancy, and 
perforated bowel, under the listings in the affected body systems.
    d. Hepatorenal syndrome (5.05D) is renal failure associated with 
CLD in the absence of underlying kidney pathology. Findings 
associated with hepatorenal syndrome include elevation of serum 
creatinine, sodium retention with low urinary sodium excretion, and 
oliguria (reduced output of urine). We evaluate renal dysfunction 
with known underlying kidney pathology, such as glomerulonephritis, 
tubular necrosis, and renal infections under the listings in 6.00.
    e. Hepatopulmonary syndrome (5.05E) is arterial deoxygenation 
(hypoxemia) due to intrapulmonary vascular dilation and 
arteriovenous shunting, associated with CLD. We evaluate pulmonary 
dysfunction with known underlying respiratory pathology, such as 
asthma, pneumonia, and pulmonary infections, under the listings in 
3.00.
    (i) Under 5.05E1, we require a resting arterial blood gas (ABG) 
measurement obtained while you are breathing room air; that is, 
without oxygen supplementation. The ABG report must include the 
PaO2 value, your name, the date of the test, 
and either the altitude or both the city and State of the test site.
    (ii) We will not purchase the specialized imaging techniques 
described in 5.05E2; however, if you have had the test(s) at a time 
relevant to your claim, we will make every reasonable effort to 
obtain the report.
    f. Hepatic encephalopathy (5.05F), also known as portosystemic 
encephalopathy, is a recurrent or chronic neuropsychiatric disorder 
associated with CLD.
    (i) Under 5.05F2, we require documentation of a mental 
impairment associated with hepatic encephalopathy. A mental 
impairment can include abnormal behavior, changes in mental status, 
or an altered state of consciousness. Reports of abnormal behavior 
may show that you are experiencing delusions, paranoia, or 
hallucinations. Reports of changes in mental status may show change 
in sleep patterns, personality or mood changes, poor concentration, 
or poor judgment or cognitive dysfunction (for example, impaired 
memory, poor problem-solving ability, or attention deficits). 
Reports of altered state of consciousness may show that you are 
experiencing confusion, delirium, or stupor.
    (ii) Signs and laboratory findings that document the severity of 
hepatic encephalopathy when not attributable to

[[Page 35946]]

other causes may include a ``flapping tremor'' (asterixis), 
characteristic abnormalities found on an electroencephalogram (EEG), 
or abnormal serum albumin or coagulation values. We will not 
purchase an EEG; however, if you have had this test at a time 
relevant to your claim, we will make every reasonable effort to 
obtain the report for the purpose of establishing whether your 
impairment meets the criteria of 5.05F.
    (iii) We will not evaluate acute encephalopathy under 5.05F if 
it results from conditions other than CLD. For example, we will 
evaluate acute encephalopathy caused by vascular events under the 
listings in 11.00 and acute encephalopathy caused by cancer under 
the listings in 13.00.
    3. SSA CLD score (5.05G). Listing 5.05G requires two SSA CLD 
scores, each requiring three laboratory values. The ``date of the 
SSA CLD score'' is the date of the earliest of the three laboratory 
values used for its calculation. The date of the second SSA CLD 
score must be at least 60 days after the date of the first SSA CLD 
score and both scores must be within the required 12-month period.
    a. We calculate the SSA CLD score using a formula that includes 
three laboratory values: Serum creatinine (mg/dL), total bilirubin 
(mg/dL), and INR. The formula for the SSA CLD score calculation is:

9.57 x [loge(serum creatinine mg/dL)] + 3.78 x 
[loge(serum total bilirubin mg/dL)] + 11.2 x 
[loge(INR)] + 6.43

    b. When we indicate ``loge'' (also abbreviated 
``ln'') in the formula for the SSA CLD score calculation, we mean 
the ``base e logarithm'' or ``natural logarithm'' of the numerical 
laboratory value, not the ``base 10 logarithm'' or ``common 
logarithm'' (log) of the laboratory value, and not the actual 
laboratory value. For example, if a person has laboratory values of 
serum creatinine 2.0 mg/dL, serum total bilirubin 1.5 mg/dL, and INR 
1.0, we compute the SSA CLD score as follows:

9.57 x [loge(serum creatinine 2.0 mg/dL) = 0.693] + 3.78 
x [loge(serum total bilirubin 1.5 mg/dL) = 0.405] + 11.2 
x [loge(INR 1.0) = 0] + 6.43
= 6.63 + 1.53 + 0 + 6.43
= 14.6, which we round to an SSA CLD score of 15.

    c. For any SSA CLD score calculation, all of the required 
laboratory values (serum creatinine, serum total bilirubin, and INR) 
must have been obtained within a continuous 30-day period. We round 
any of the required laboratory values less than 1.0 up to 1.0 to 
calculate your SSA CLD score. If there are multiple laboratory 
values within the 30-day interval for any given laboratory test, we 
use the highest value to calculate your SSA CLD score. If you are in 
renal failure or on dialysis within a week of any serum creatinine 
test in the period used for the SSA CLD calculation, we will use a 
serum creatinine value of 4, which is the maximum serum creatinine 
level allowed in the calculation, to calculate your SSA CLD score. 
We will not use any INR values derived from testing done while you 
are on anticoagulant treatment in our SSA CLD calculation. We round 
the results of your SSA CLD score calculation to the nearest whole 
integer to arrive at your SSA CLD score.
    D. What is inflammatory bowel disease (IBD), and how do we 
evaluate it under 5.06?
    1. IBD is a group of inflammatory conditions of the small 
intestine and colon. The most common IBD disorders are Crohn's 
disease and ulcerative colitis. Remissions and exacerbations of 
variable duration are a hallmark of IBD.
    2. We evaluate your signs and symptoms of IBD, such as diarrhea, 
fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever, 
nausea, vomiting, arthralgia, abdominal tenderness, and palpable 
abdominal mass (usually inflamed loops of bowel), when we assess the 
severity of your impairment(s).
    3. We consider other signs or laboratory findings of IBD that 
indicate malnutrition, such as anemia, edema, weight loss, or 
hypoalbuminemia, when we determine your ability to maintain adequate 
nutrition. We evaluate your inability to maintain adequate nutrition 
under 5.08.
    4. Repeated complications of IBD.
    a. Examples of complications of IBD include abscesses, 
intestinal perforation, toxic megacolon, infectious colitis, 
pyoderma gangrenosum, ureteral obstruction, primary sclerosing 
cholangitis, and hypercoagulable state (which may lead to thromboses 
or embolism). When we evaluate repeated complications of IBD, we 
consider all relevant information in your case record to determine 
the effects of your IBD on your ability to function independently, 
appropriately, effectively, and on a sustained basis. Factors we 
consider include, but are not limited to: Your symptoms, the 
frequency and duration of your complications, periods of 
exacerbation and remission, and the functional effects of your 
treatment, including the side effects of your medication. Your 
impairment will satisfy this criterion regardless of whether you 
have the same kind of complication repeatedly, all different 
complications, or any other combination of complications; for 
example, two of the same kind of complication and a different one.
    b. To satisfy the requirements described under 5.06C, your IBD 
must result in repeated complications and marked limitation in one 
of three areas of functioning: Activities of daily living; 
maintaining social functioning; or completing tasks in a timely 
manner due to deficiencies in concentration, persistence, or pace. 
If the complications do not last as long or occur as frequently as 
required under 5.06C, we will consider whether your IBD medically 
equals the listing.
    c. Marked limitation means that the signs and symptoms of your 
IBD interfere seriously with your ability to function. Although we 
do not require the use of such a scale, ``marked'' would be the 
fourth point on a five-point rating scale consisting of no 
limitation, mild limitation, moderate limitation, marked limitation, 
and extreme limitation. We do not define ``marked'' by a specific 
number of activities of daily living or different behaviors in which 
your social functioning is impaired, or a specific number of tasks 
that you are able to complete, but by the nature and overall degree 
of interference with your functioning. You may have marked 
limitation when several activities or functions are impaired, or 
when only one is impaired. Additionally, you need not be totally 
precluded from performing an activity to have marked limitation, as 
long as the degree of limitation interferes seriously with your 
ability to function independently, appropriately, and effectively. 
The term ``marked'' does not imply that you must be confined to bed, 
hospitalized, or in a nursing home.
    d. Activities of daily living include, but are not limited to, 
such activities as doing household chores, grooming and hygiene, 
using a post office, taking public transportation, or paying bills. 
We will find that you have ``marked'' limitation in activities of 
daily living if you have a serious limitation in your ability to 
maintain a household or take public transportation because of 
symptoms, such as pain, severe fatigue, anxiety, or difficulty 
concentrating, caused by your IBD (including complications of the 
disorder) or its treatment, even if you are able to perform some 
self-care activities.
    e. Maintaining social functioning includes the capacity to 
interact independently, appropriately, effectively, and on a 
sustained basis with others. It includes the ability to communicate 
effectively with others. We will find that you have ``marked'' 
limitation in maintaining social functioning if you have a serious 
limitation in social interaction on a sustained basis because of 
symptoms, such as pain, severe fatigue, anxiety, or difficulty 
concentrating, or a pattern of exacerbation and remission, caused by 
your IBD (including complications of the disorder) or its treatment, 
even if you are able to communicate with close friends or relatives.
    f. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace involves the ability to sustain 
concentration, persistence, or pace to permit timely completion of 
tasks commonly found in work settings. We will find that you have 
``marked'' limitation in completing tasks if you have a serious 
limitation in your ability to sustain concentration or pace adequate 
to complete work-related tasks because of symptoms, such as pain, 
severe fatigue, anxiety, or difficulty concentrating, caused by your 
IBD (including complications of the disorder) or its treatment, even 
if you are able to do some routine activities of daily living.
    E. What is short bowel syndrome (SBS), and how do we evaluate it 
under 5.07?
    1. SBS is a malabsorption disorder that occurs when ischemic 
vascular insults (caused, for example, by volvulus or necrotizing 
enterocolitis), trauma, or IBD complications require(s) surgical 
resection of any amount of the small intestine, resulting in chronic 
malnutrition.
    2. We require a copy of the operative report that includes 
details of the surgical findings, or postoperative imaging 
indicating a resection of the small intestine. If we cannot get one 
of these reports, we need other medical reports that include details 
of the surgical findings. We also need medical documentation that 
you are dependent on daily parenteral nutrition to provide most of 
your nutritional requirements.
    F. How do we evaluate malnutrition due to any digestive disorder 
under 5.08?

[[Page 35947]]

    1. We evaluate malnutrition due to any digestive disorder using 
two body mass index (BMI) measurements at least 60 days apart in 
combination with an abnormal laboratory finding. If you have more 
than two BMI measurements within a consecutive 12-month period, we 
will use your two lowest BMI measurements that are at least 60 days 
apart.
    2. BMI is the ratio of your weight to the square of your height.
    a. We use measurements of your weight and height without shoes 
for these calculations.
    b. We calculate BMI using one of the following formulas:

English Formula

BMI = [Weight in Pounds/(Height in Inches x Height in Inches)] x 703

Metric Formulas

BMI = Weight in Kilograms/(Height in Meters x Height in Meters)
BMI = [Weight in Kilograms/(Height in Centimeters x Height in 
Centimeters)] x 10,000

    G. How do we evaluate digestive organ transplantation? If you 
receive a liver (5.09), small intestine (5.11), or pancreas (5.12) 
transplant, we will consider you to be disabled under the listing 
for 1 year from the date of the transplant. After that, we evaluate 
your residual impairment(s) by considering the adequacy of your 
post-transplant function, the frequency and severity of any 
rejection episodes you have, complications in other body systems, 
and adverse treatment effects. People who receive digestive organ 
transplants generally have impairments that meet our definition of 
disability before they undergo transplantation. The phrase 
``consider under a disability for 1 year'' in 5.09, 5.11, and 5.12 
does not refer to the date on which your disability began, only to 
the date on which we must reevaluate whether your impairment(s) 
continues to meet a listing or is otherwise disabling. We determine 
the onset of your disability based on the facts of your case.
    H. How do we evaluate your digestive disorder if there is no 
record of ongoing treatment? If there is no record of ongoing 
treatment despite the existence of a severe impairment(s), we will 
assess the severity and duration of your digestive disorder based on 
the current medical and other evidence in your case record. If there 
is no record of ongoing treatment, you may not be able to show an 
impairment that meets a digestive disorders listing, but your 
impairment may medically equal a listing, or be disabling based on 
consideration of your residual functional capacity, age, education, 
and work experience.
    I. How do we evaluate your digestive disorder if there is 
evidence establishing a substance use disorder? If we find that you 
are disabled and there is medical evidence in your case record 
establishing that you have a substance use disorder, we will 
determine whether your substance use disorder is a contributing 
factor material to the determination of disability. See Sec.  
404.1535 and Sec.  416.935 of this chapter. Digestive disorders 
resulting from drug or alcohol use are often chronic in nature and 
will not necessarily improve with cessation in drug or alcohol use.
    J. How do we evaluate digestive disorders that do not meet one 
of these listings?
    1. These listings are only examples of common digestive 
disorders that we consider severe enough to prevent you from doing 
any gainful activity. If your impairment(s) does not meet the 
criteria of any of these listings, we must also consider whether you 
have an impairment(s) that satisfies the criteria of a listing in 
another body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec.  404.1526 and 
Sec.  416.926 of this chapter. Digestive disorders may be associated 
with disorders in other body systems, and we consider the combined 
effects of multiple impairments when we determine whether they 
medically equal a listing. If your impairment(s) does not meet or 
medically equal a listing, you may or may not have the residual 
functional capacity to engage in substantial gainful activity. We 
proceed to the fourth step and, if necessary, the fifth step of the 
sequential evaluation process in Sec.  404.1520 and Sec.  416.920 of 
this chapter. We use the rules in Sec.  404.1594 and Sec.  416.994 
of this chapter, as appropriate, when we decide whether you continue 
to be disabled.
    5.01 Category of Impairments, Digestive Disorders
    5.02 Gastrointestinal hemorrhaging from any cause, requiring 
three blood transfusions of at least 2 units of blood per 
transfusion, within a consecutive 12-month period and at least 30 
days apart. Consider under a disability for 1 year following the 
last documented transfusion; after that, evaluate the residual 
impairment(s).
    5.03-5.04 [Reserved]
    5.05 Chronic liver disease (CLD) (see 5.00C) with A, B, C, D, E, 
F, or G:
    A. Hemorrhaging from esophageal, gastric, or ectopic varices, or 
from portal hypertensive gastropathy (see 5.00C2a), documented by 
imaging (see 5.00B3); resulting in hemodynamic instability indicated 
by signs such as pallor (pale skin), diaphoresis (profuse 
perspiration), rapid pulse, low blood pressure, postural hypotension 
(pronounced fall in blood pressure when arising to an upright 
position from lying down, or syncope (fainting); and requiring 
hospitalization for transfusion of at least two units of blood. 
Consider under a disability for 1 year following the documented 
transfusion; after that, evaluate the residual impairment(s).

OR

    B. Ascites or hydrothorax not attributable to other causes (see 
5.00C2b), present on two evaluations within a consecutive 12-month 
period and at least 60 days apart. Each evaluation must document the 
ascites or hydrothorax by 1, 2, or 3:
    1. Paracentesis; or
    2. Thoracentesis; or
    3. Imaging or physical examination with a or b:
    a. Serum albumin of 3.0 g/dL or less; or
    b. INR of at least 1.5.

OR

    C. Spontaneous bacterial peritonitis (see 5.00C2c) documented by 
peritoneal fluid containing a neutrophil count of at least 250 
cells/mm\3\.

OR

    D. Hepatorenal syndrome (see 5.00C2d) documented by 1, 2, or 3:
    1. Serum creatinine elevation of at least 2 mg/dL; or
    2. Oliguria with 24-hour urine output less than 500 mL; or
    3. Sodium retention with urine sodium less than 10 mEq per 
liter.

OR

    E. Hepatopulmonary syndrome (see 5.00C2e) documented by 1 or 2:
    1. Arterial PaO2 measured by an ABG test, 
while at rest, breathing room air, less than or equal to:
    a. 60 mm Hg, at test sites less than 3,000 feet above sea level; 
or
    b. 55 mm Hg, at test sites from 3,000 through 6,000 feet above 
sea level; or
    c. 50 mm Hg, at test sites over 6,000 feet above sea level; or
    2. Intrapulmonary arteriovenous shunting as shown by contrast-
enhanced echocardiography or macroaggregated albumin lung perfusion 
scan.

OR

    F. Hepatic encephalopathy (see 5.00C2f) with documentation of 
abnormal behavior, cognitive dysfunction, changes in mental status, 
or altered state of consciousness (for example, confusion, delirium, 
stupor, or coma), present on two evaluations within a consecutive 
12-month period and at least 60 days apart and either 1 or 2:
    1. History of transjugular intrahepatic portosystemic shunt 
(TIPS) or other surgical portosystemic shunt; or
    2. One of the following on at least two evaluations at least 60 
days apart within the same consecutive 12-month period as in F:
    a. Asterixis or other fluctuating physical neurological 
abnormalities; or
    b. EEG demonstrating triphasic slow wave activity; or
    c. Serum albumin of 3.0 g/dL or less; or
    d. INR of 1.5 or greater.

OR

    G. Two SSA CLD scores (see 5.00C3) of at least 20 within a 
consecutive 12-month period and at least 60 days apart.
    5.06 Inflammatory bowel disease (IBD) (see 5.00D) documented by 
endoscopy, biopsy, imaging, or operative findings, and demonstrated 
by A, B, or C:
    A. Obstruction of stenotic areas (not adhesions) in the small 
intestine or colon with proximal dilatation, confirmed by imaging or 
in surgery, requiring two hospitalizations for intestinal 
decompression or for surgery, within a consecutive 12-month period 
and at least 60 days apart.

OR

    B. Two of the following occurring within a consecutive 12-month 
period and at least 60 days apart:
    1. Clinically documented tender abdominal mass palpable on 
physical examination with abdominal pain or cramping; or

[[Page 35948]]

    2. Perineal disease with a draining abscess or fistula; or
    3. Need for supplemental daily enteral nutrition via a 
gastrostomy or daily parenteral nutrition via a central venous 
catheter.

OR

    C. Repeated complications of IBD (see 5.00D4a), occurring an 
average of three times a year, or once every 4 months, each lasting 
2 weeks or more, within a consecutive 12-month period, and marked 
limitation (see 5.00D4c) in one of the following:
    1. Activities of daily living (see 5.00D4d); or
    2. Maintaining social functioning (see 5.00D4e); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 5.00D4f).
    5.07 Short bowel syndrome (SBS) (see 5.00E) due to surgical 
resection of any amount of the small intestine, resulting in 
dependence on daily parenteral nutrition via a central venous 
catheter.
    5.08 Malnutrition due to any digestive disorder (see 5.00F), 
documented by A and B:
    A. One of the following:
    1. Anemia with hemoglobin of less than 10.0 g/dL, present on two 
evaluations within a consecutive 12-month period and at least 60 
days apart; or
    2. Serum albumin of 3.0 g/dL or less, present on two evaluations 
within a consecutive 12-month period and at least 60 days apart.

AND

    B. Two BMI measurements of less than 18.0 (see 5.00F2) within a 
consecutive 12-month period and at least 60 days apart.
    5.09 Liver transplantation (see 5.00G). Consider under a 
disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).
    5.10 [Reserved]
    5.11 Small intestine transplantation (see 5.00G). Consider under 
a disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).
    5.12 Pancreas transplantation (see 5.00G). Consider under a 
disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).
* * * * *

8.00 Skin Disorders

    A. Which skin disorders do we evaluate under these listings? We 
use these listings to evaluate skin disorders that result from 
hereditary, congenital, or acquired pathological processes. We 
evaluate genetic photosensitivity disorders (8.07), burns (8.08), 
and chronic conditions of the skin or mucous membranes such as 
ichthyosis, bullous disease, dermatitis, psoriasis, and hidradenitis 
suppurativa (8.09).
    B. What are our definitions for the following terms used in this 
body system?
    1. Assistive device(s): An assistive device, for the purposes of 
these listings, is any device used to improve stability, dexterity, 
or mobility. An assistive device can be hand-held, such as a 
cane(s), a crutch(es), or a walker; or worn, such as a prosthesis or 
an orthosis.
    2. Chronic skin lesions: Chronic skin lesions can have recurrent 
exacerbations. They can occur despite prescribed medical treatment. 
These chronic skin lesions can develop on any part of your body, 
including upper extremities, lower extremities, palms of your hands, 
soles of your feet, the perineum, inguinal (groin) region, and 
axillae (underarms). Chronic skin lesions may result in functional 
limitations as described in 8.00D2.
    3. Contractures: Contractures are permanent fibrous scar tissue 
resulting in tightening and thickening of skin that prevents normal 
movement of the damaged area. They can develop on any part of your 
musculoskeletal system, including upper extremities, lower 
extremities, palms of your hands, soles of your feet, the perineum, 
inguinal (groin) region, and axillae (underarms). Contractures may 
result in functional limitations as described in 8.00D2.
    4. Documented medical need: When we use the term ``documented 
medical need,'' we mean that there is evidence from your medical 
source(s) in the medical record that supports your need for an 
assistive device (see Sec.  404.1513 and Sec.  416.913 of this 
chapter). The evidence must include documentation from your medical 
source(s) describing any limitation(s) in your upper or lower 
extremity functioning that supports your need for the assistive 
device, and describing the circumstances for which you need it. The 
evidence does not have to include a specific prescription for the 
device.
    5. Fine and gross movements: Fine movements, for the purposes of 
these listings, involve use of your wrists, hands, and fingers; such 
movements include picking, pinching, manipulating, and fingering. 
Gross movements involve use of your shoulders, upper arms, forearms, 
and hands; such movements include handling, gripping, grasping, 
holding, turning, and reaching. Gross movements also include 
exertional activities such as lifting, carrying, pushing, and 
pulling.
    6. Surgical management: For the purposes of these listings, 
surgical management includes the surgery(-ies) itself, as well as 
various post-surgical procedures, surgical complications, infections 
or other medical complications, related illnesses, or related 
treatments that delay a person's attainment of maximum benefit from 
surgery.
    C. What evidence do we need to evaluate your skin disorder?
    1. To establish the presence of a skin disorder as a medically 
determinable impairment, we need objective medical evidence from an 
acceptable medical source who has examined you for the disorder.
    2. We will make every reasonable effort to obtain your medical 
history, treatment records, and relevant laboratory findings, but we 
will not purchase genetic testing.
    3. When we evaluate the presence and severity of your skin 
disorder(s), we generally need information regarding:
    a. The onset, duration, and frequency of exacerbations;
    b. The prognosis of your skin disorder;
    c. The location, size, and appearance of lesions and 
contractures;
    d. Your history of familial incidence; exposure to toxins, 
allergens or irritants; seasonal variations; and stress factors;
    e. Your ability to function outside of a highly protective 
environment;
    f. Laboratory findings (for example, a biopsy obtained 
independently of Social Security disability evaluation or results of 
blood tests);
    g. Evidence from other medically acceptable methods consistent 
with the prevailing state of medical knowledge and clinical 
practice; and
    h. Statements you or others make about your disorder(s), your 
restrictions, and your daily activities.
    D. How do we evaluate the severity of skin disorders?
    1. General. We evaluate the severity of skin disorders based on 
the site(s) of your chronic skin lesions or contractures, functional 
limitations caused by your signs and symptoms (including pain) (see 
8.00D2), and how your prescribed treatment affects you. We consider 
the frequency and severity of your exacerbations, how quickly they 
resolve, and how you function between exacerbations, to determine 
whether your skin disorder meets or medically equals a listing. If 
there is no record of ongoing medical treatment for your disorder, 
we will follow the guidelines in 8.00D6. We will determine the 
extent and kinds of evidence we need from medical and non-medical 
sources based on the individual facts about your disorder. For our 
basic rules on evidence, see Sec. Sec.  404.1512, 404.1513, and 
404.1520b and Sec. Sec.  416.912, 416.913, and 416.920b of this 
chapter. For our rules on evaluating your symptoms, see Sec.  
404.1529 and Sec.  416.929 of this chapter.
    2. Limitation(s) of physical functioning due to skin disorders.
    a. Skin disorders may be due to chronic skin lesions (see 
8.00B2) or contractures (see 8.00B3), and may cause pain or restrict 
movement, which can limit your ability to initiate, sustain, and 
complete work-related activities. For example, skin lesions in the 
axilla may limit your ability to raise or reach with the affected 
arm, or lesions in the inguinal region may limit your ability to 
ambulate, sit, or lift and carry. To evaluate your skin disorder(s) 
under 8.07B, 8.08, and 8.09, we require medically documented 
evidence of physical limitation(s) of functioning related to your 
disorder. The decrease in physical function must have lasted, or can 
be expected to last, for a continuous period of at least 12 months 
(see Sec.  404.1509 and Sec.  416.909 of this chapter). Xeroderma 
pigmentosum is the only skin disorder that does not include 
functional criteria because the characteristics and severity of the 
disorder itself are sufficient to meet the criteria in 8.07A.
    b. The functional criteria require impairment-related physical 
limitations in using upper or lower extremities that have lasted, or 
can be expected to last, for a continuous period of at least 12 
months, medically documented by one of the following:
    (i) Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete

[[Page 35949]]

work-related activities involving fine and gross movements;
    (ii) Inability to use one upper extremity to independently 
initiate, sustain, and complete work-related activities involving 
fine and gross movements due to chronic skin lesions or 
contractures, and a documented medical need for a one-handed 
assistive device that requires the use of your other upper 
extremity; or
    (iii) Inability to stand up from a seated position and maintain 
an upright position to the extent you can independently initiate, 
sustain, and complete work-related activities due to chronic skin 
lesions or contractures affecting at least two extremities 
(including when the limitations are due to involvement of the 
perineum or the inguinal region); or
    (iv) Inability to maintain an upright position while standing or 
walking, to independently initiate, sustain, and complete work-
related activities due to chronic skin lesions or contractures 
affecting both lower extremities (including when the limitations are 
due to involvement of the perineum or the inguinal region).
    3. Frequency of exacerbations due to chronic skin lesions. A 
skin disorder resulting in chronic skin lesions (see 8.00B2) may 
have frequent exacerbations severe enough to meet a listing even if 
each individual skin lesion exacerbation did not last for an 
extended amount of time. We will consider the frequency, severity, 
and duration of skin lesion exacerbations; how quickly they resolve; 
and how you function in the time between skin lesion exacerbations, 
to determine whether your skin disorder meets or equals a listing.
    4. Symptoms (including pain). Your symptoms may be an important 
factor in our determination of whether your skin disorder(s) meets 
or medically equals a listing, or whether you are otherwise able to 
work. We consider your symptoms only when you have a medically 
determinable impairment that could reasonably be expected to produce 
the symptoms. See Sec.  404.1529 and Sec.  416.929 of this chapter.
    5. Treatment.
    a. General. Treatments for skin disorders may have beneficial or 
adverse effects, and responses to treatment vary from person to 
person. Your skin disorder's response to treatment may vary due to 
treatment resistance or side effects that can result in functional 
limitations. We will evaluate all of the effects of treatment 
(including surgical treatment, medications, and therapy) on the 
symptoms, signs, and laboratory findings of your skin disorder, and 
on your ability to function.
    b. Despite adherence to prescribed medical treatment for 3 
months. Under 8.09, we require that your symptoms persist ``despite 
adherence to prescribed medical treatment for 3 months.'' This 
requirement means that you must have taken prescribed medication(s) 
or followed other medical treatment prescribed by a physician for 3 
consecutive months. Treatment or effects of treatment may be 
temporary. In most cases, sufficient time must elapse to allow us to 
evaluate your response to treatment, including any side effects. For 
our purposes, ``sufficient time'' means a period of at least 3 
months. If your treatment has not lasted for at least 3 months, we 
will follow the rules in 8.00D6a. To evaluate the severity of 
physical limitations due to your skin disorder(s), we require 
medically documented evidence of disorder-related physical 
limitation(s) of functioning that has lasted, or can be expected to 
last, for a continuous period of at least 12 months. See Sec.  
404.1509 and Sec.  416.909 of this chapter. The 3 months adherence 
to prescribed medical treatment must be within the period of at 
least 12 months that we use to evaluate severity.
    c. Treatment with PUVA (psoralen and ultraviolet A (UVA) light) 
or biologics. If you receive additional treatment with PUVA or 
biologics to treat your skin disorder(s), we will defer adjudication 
of your claim for 6 months from the start of treatment with PUVA or 
biologics to evaluate the effectiveness of these treatments unless 
we can make a fully favorable determination or decision on another 
basis.
    6. No record of ongoing treatment.
    a. Despite having a skin disorder, you may not have received 
ongoing treatment, may have just begun treatment, may not have 
access to prescribed medical treatment, or may not have an ongoing 
relationship with the medical community. In any of these situations, 
you will not have a longitudinal medical record for us to review 
when we evaluate your disorder. In some instances, we may be able to 
assess the severity and duration of your skin disorder based on your 
medical record and current evidence alone. We may ask you to attend 
a consultative examination to determine the severity and potential 
duration of your skin disorder (see Sec.  404.1519a and Sec.  
416.919a of this chapter).
    b. If, for any reason, you have not received treatment, your 
skin disorder cannot meet the criteria for 8.09. If the information 
in your case record is not sufficient to show that you have a skin 
disorder that meets the criteria of one of the skin disorders 
listings, we will follow the rules in 8.00I.
    E. How do we evaluate genetic photosensitivity disorders under 
8.07? Genetic photosensitivity disorders are disorders of the skin 
caused by an increase in the sensitivity of the skin to sources of 
ultraviolet light, including sunlight.
    1. Xeroderma pigmentosum (XP) (8.07A). XP is a genetic 
photosensitivity disorder with lifelong hypersensitivity to all 
forms of ultraviolet light. Laboratory testing confirms the 
diagnosis by documenting abnormalities in the body's ability to 
repair DNA (deoxyribonucleic acid) mutations after ultraviolet light 
exposure. Your skin disorder meets the requirements of 8.07A if you 
have clinical and laboratory findings supporting a diagnosis of XP 
(see 8.00E3).
    2. Other genetic photosensitivity disorders (8.07B). The effects 
of other genetic photosensitivity disorders may vary and may not 
persist over time. To meet the requirements of 8.07B, a genetic 
photosensitivity disorder other than XP must be established by 
clinical and laboratory findings (see 8.00C) and must result either 
in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) 
that result in functional limitations (see 8.00D), or must result in 
the inability to function outside of a highly protective 
environment. Some genetic photosensitivity disorders can have very 
serious effects on other body systems, especially special senses and 
speech, neurological, mental, and cancer. We will evaluate your 
disorder(s) under the listings in 2.00, 11.00, 12.00, or 13.00, as 
appropriate.
    3. What evidence do we need to document that you have XP or 
another genetic photosensitivity disorder? We will make a reasonable 
effort to obtain evidence of your disorder(s), but we will not 
purchase genetic testing. When the results of genetic tests are part 
of the existing evidence in your case record, we will evaluate the 
test results with all other relevant evidence. We need the following 
clinical and laboratory findings to document that you have XP or 
another genetic photosensitivity disorder:
    a. A laboratory report of a definitive genetic laboratory test 
documenting appropriate chromosomal changes, including abnormal DNA 
repair or another DNA abnormality specific to your type of 
photosensitivity disorder, signed by an acceptable medical source 
(AMS); or
    b. A laboratory report of a definitive test that is not signed 
by an AMS, and a report from an AMS stating that you have undergone 
definitive genetic laboratory studies documenting appropriate 
chromosomal changes, including abnormal DNA repair or another DNA 
abnormality specific to your type of photosensitivity disorder; or
    c. If we do not have a laboratory report of a definitive test, 
we need documentation from an AMS that an appropriate laboratory 
analysis or other diagnostic method(s) confirms a positive diagnosis 
of your skin disorder. This documentation must state that you had 
the appropriate definitive laboratory test(s) for diagnosing your 
disorder and provide the results, or explain how another diagnostic 
method(s), consistent with the prevailing state of medical knowledge 
and clinical practice, established your diagnosis.
    4. Inability to function outside of a highly protective 
environment means that you must avoid exposure to ultraviolet light 
(including sunlight passing through windows and light from similar 
unshielded light sources), wear protective clothing and eyeglasses, 
and use opaque broad-spectrum sunscreens in order to avoid skin 
cancer or other serious effects.
    F. How do we evaluate burns under 8.08?
    1. Electrical, chemical, or thermal burns frequently affect 
other body systems, for example, musculoskeletal, special senses and 
speech, respiratory, cardiovascular, genitourinary, neurological, or 
mental. We evaluate burns in the same way we evaluate other 
disorders that can affect the skin and other body systems, using the 
listing for the predominant feature of your disorder. For example, 
if your soft tissue injuries resulting from burns are under surgical 
management (as defined in 8.00B6), we will evaluate your disorder 
under the listings in 1.00.
    2. We evaluate third-degree burns resulting in contractures (see 
8.00B3) that have been documented by an acceptable medical source to 
have reached maximum therapeutic benefit and therefore are no longer 
receiving surgical management, under 8.08. To be

[[Page 35950]]

disabling, these burns must result in functional limitation(s) (see 
8.00D2) that has lasted or can be expected to last for a continuous 
period of at least 12 months.
    G. How do we evaluate chronic conditions of the skin or mucous 
membranes under 8.09? We evaluate skin disorders that result in 
chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) under 
8.09. These disorders must result in chronic skin lesions or 
contractures that continue to persist despite adherence to 
prescribed medical treatment for 3 months (see 8.00D5b) and cause 
functional limitations (see 8.00D2). Examples of skin disorders 
evaluated under this listing are ichthyosis, bullous diseases (such 
as pemphigus, epidermolysis bullosa, and dermatitis herpetiformis), 
chronic skin infections, dermatitis, psoriasis, and hidradenitis 
suppurativa.
    H. How do we evaluate disorders in other body systems that 
affect the skin? When your disorder(s) in another body system 
affects the skin, we first evaluate the predominant feature of your 
disorder(s) under the appropriate body system. Examples of disorders 
in other body systems that may affect the skin include the 
following:
    1. Diabetes mellitus. Diabetes mellitus that is not well 
controlled, despite treatment, can cause chronic hyperglycemia 
resulting in serious, long-lasting or recurrent exacerbations or 
complications. We evaluate those exacerbations or complications 
under the affected body system(s). If the complication involves soft 
tissue or amputation(s), we evaluate these features under the 
listings in 1.00. If the exacerbations or complications involve 
chronic bacterial or fungal skin lesions resulting from diabetes 
mellitus, we evaluate your limitations from the skin disorder under 
listing 8.09.
    2. Tuberous sclerosis. The predominant functionally limiting 
features of tuberous sclerosis are seizures and intellectual 
disability or other mental disorders. We evaluate these features 
under the listings in 11.00 or 12.00, as appropriate.
    3. Malignant tumors of the skin. Malignant tumors of the skin 
(for example, malignant melanomas) are cancers, or malignant 
neoplastic diseases, that we evaluate under the listings in 13.00.
    4. Immune system disorders. We evaluate skin manifestations of 
immune system disorders such as systemic lupus erythematosus, 
scleroderma, psoriasis, and human immunodeficiency virus (HIV) 
infection under the listings in 14.00.
    5. Head or facial disfigurement or deformity, and other physical 
deformities caused by skin disorders. A head or facial disfigurement 
or deformity may result in loss of your sight, hearing, speech, or 
ability to chew. In addition to head and facial disfigurement and 
deformity, other physical deformities may result in associated 
psychological problems (for example, depression). We evaluate the 
effects of head or facial disfigurement or deformity, or other 
physical deformities caused by skin disorders under the listings in 
1.00, 2.00, 5.00, or 12.00, as appropriate.
    I. How do we evaluate skin disorders that do not meet one of 
these listings?
    1. These listings are only examples of common skin disorders 
that we consider severe enough to prevent you from doing any gainful 
activity. If your impairment(s) does not meet the criteria of any of 
these listings, we must also consider whether you have an 
impairment(s) that satisfies the criteria of a listing in another 
body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec.  404.1526 and 
Sec.  416.926 of this chapter. If your impairment(s) does not meet 
or medically equal a listing, you may or may not have the residual 
functional capacity to engage in substantial gainful activity. We 
proceed to the fourth step and, if necessary, the fifth step of the 
sequential evaluation process in Sec.  404.1520 and Sec.  416.920 of 
this chapter. We use the rules in Sec.  404.1594 and Sec.  416.994 
of this chapter, as appropriate, when we decide whether you continue 
to be disabled.
    8.01 Category of Impairments, Skin Disorders
    8.02-8.06 [Reserved]
    8.07 Genetic photosensitivity disorders, established as 
described in 8.00E. The requirements of this listing are met if 
either paragraph A or paragraph B is satisfied.
    A. Xeroderma pigmentosum (see 8.00E1).

OR

    B. Other genetic photosensitivity disorders (see 8.00E2) with 
either 1 or 2:
    1. Chronic skin lesions (see 8.00B2) or contractures (see 
8.00B3) that cause an inability to function outside of a highly 
protective environment (see 8.00E4); or
    2. Chronic skin lesions (see 8.00B2) or contractures (see 
8.00B3) that cause functional limitations (see 8.00D2) due to 
limitation(s) from your skin condition, such as pain, as evidenced 
by:
    a. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
work-related activities involving fine and gross movements; or
    b. Inability to use one upper extremity to independently 
initiate, sustain, and complete work-related activities involving 
fine and gross movements (due to chronic skin lesions or 
contractures), and a documented medical need for a one-handed 
assistive device that requires the use of your other upper 
extremity; or
    c. Inability to stand up from a seated position and maintain an 
upright position to the extent you can independently initiate, 
sustain, and complete work-related activities due to chronic skin 
lesions or contractures affecting at least two extremities 
(including when limitations are due to involvement of the perineum 
or the inguinal region); or
    d. Inability to maintain an upright position while standing or 
walking, to independently initiate, sustain, and complete work-
related activities due to chronic skin lesions or contractures 
affecting both lower extremities (including when the limitations are 
due to involvement of the perineum or the inguinal region).
    8.08 Burns (see 8.00F). Third-degree burns that do not require 
continuing surgical management, or that have been documented by an 
acceptable medical source to have reached maximum therapeutic 
benefit and therefore are no longer receiving surgical management, 
resulting in chronic skin lesions (see 8.00B2) or contractures (see 
8.00B3) that cause functional limitations (see 8.00D2) due to 
limitation(s), such as pain, from your skin condition, as evidenced 
by:
    A. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
work-related activities involving fine and gross movements.

OR

    B. Inability to use one upper extremity to independently 
initiate, sustain, and complete work-related activities involving 
fine and gross movements (due to chronic skin lesions or 
contractures), and a documented medical need for a one-handed 
assistive device that requires the use of your other upper 
extremity.

OR

    C. Inability to stand up from a seated position and maintain an 
upright position to the extent you can independently initiate, 
sustain, and complete work-related activities due to chronic skin 
lesions or contractures affecting at least two extremities 
(including when the limitations are due to involvement of the 
perineum or the inguinal region).

OR

    D. Inability to maintain an upright position while standing or 
walking, to independently initiate, sustain, and complete work-
related activities due to chronic skin lesions or contractures 
affecting both lower extremities (including when the limitations are 
due to involvement of the perineum or the inguinal region).
    8.09 Chronic conditions of the skin or mucous membranes (see 
8.00G) resulting in:
    A. Chronic skin lesions (see 8.00B2) or contractures (see 
8.00B3); chronic pain; or other physical limitation(s); that persist 
despite adherence to prescribed medical treatment for 3 months (see 
8.00D5b), causing functional limitations (see 8.00D2) due to 
limitation(s), such as pain, from your skin condition.

AND

    B. Impairment-related significant limitation demonstrated by 1, 
2, 3, or 4:
    1. An inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
work-related activities involving fine and gross movements; or
    2. Inability to use one upper extremity to independently 
initiate, sustain, and complete work-related activities involving 
fine and gross movements (due to chronic skin lesions or 
contractures), and a documented medical need for a one-handed 
assistive device that requires the use of your other upper 
extremity; or
    3. Inability to stand up from a seated position and maintain an 
upright position to the extent you can independently initiate, 
sustain, and complete work-related activities due to chronic skin 
lesions or contractures affecting at least two extremities 
(including when the limitations are due to involvement of the 
perineum or the inguinal region); or
    4. Inability to maintain an upright position while standing or 
walking, to independently

[[Page 35951]]

initiate, sustain, and complete work-related activities due to 
chronic skin lesions or contractures affecting both lower 
extremities (including when the limitations are due to the 
involvement of the perineum or the inguinal region).
* * * * *

Part B

* * * * *

105.00 Digestive Disorders

* * * * *

105.00 Digestive Disorders

    A. Which digestive disorders do we evaluate in this body system? 
We evaluate digestive disorders that result in severe dysfunction of 
the liver, pancreas, and gastrointestinal tract (the large, muscular 
tube that extends from the mouth to the anus, where the movement of 
muscles, along with the release of hormones and enzymes, allows for 
the digestion of food) in this body system. Examples of such 
disorders and the listings we use to evaluate them include chronic 
liver disease (105.05), inflammatory bowel disease (105.06), and 
short bowel syndrome (105.07). We also use this body system to 
evaluate gastrointestinal hemorrhaging from any cause (105.02), 
growth failure due to any digestive disorder (105.08), liver 
transplantation (105.09), need for supplemental daily enteral 
feeding via a gastrostomy due to any cause for children who have not 
attained age 3 (105.10), small intestine transplantation (105.11), 
and pancreas transplantation (105.12). We evaluate cancers affecting 
the digestive system under the listings in 113.00.
    B. What evidence do we need to evaluate your digestive disorder?
    1. General. To establish that you have a digestive disorder, we 
need medical evidence about the existence of your digestive disorder 
and its severity. Medical evidence should include your medical 
history, physical examination findings, operative reports, and 
relevant laboratory findings.
    2. Laboratory findings. We need laboratory reports such as 
results of imaging (see 105.00B3), endoscopy, and other diagnostic 
procedures. We may also need clinical laboratory and pathology 
results.
    3. Imaging refers to medical imaging techniques, such as x-ray, 
ultrasound, magnetic resonance imaging, and computerized tomography. 
The imaging must be consistent with the prevailing state of medical 
knowledge and clinical practice as a proper technique to support the 
evaluation of the disorder.
    C. What is chronic liver disease (CLD), and how do we evaluate 
it under 105.05?
    1. General. CLD is loss of liver function with cell necrosis 
(cell death), inflammation, or scarring of the liver that persists 
for more than 6 months. Common causes of CLD in children include 
chronic infection with hepatitis B virus (HBV) or hepatitis C virus 
(HCV), autoimmune hepatitis, and metabolic disease.
    a. We will evaluate your signs of CLD, such as jaundice, changes 
in size of the liver and spleen, ascites, peripheral edema, or 
altered mental status. We will also evaluate your symptoms of CLD, 
such as pruritus (itching), fatigue, nausea, loss of appetite, or 
sleep disturbances when we assess the severity of your impairment(s) 
and how it affects your ability to function. In the absence of 
evidence of a chronic liver impairment, episodes of acute liver 
disease do not meet the requirements of 105.05.
    b. Laboratory findings of your CLD may include decreased serum 
albumin, increased International Normalized Ratio (INR), arterial 
deoxygenation (hypoxemia), increased serum creatinine, oliguria 
(reduced urine output), or sodium retention. Another laboratory 
finding that may be included in the evidence is a liver biopsy. If 
you have had a liver biopsy, we will make every reasonable effort to 
obtain the results; however, we will not purchase a liver biopsy.
    2. Manifestations of CLD.
    a. Gastrointestinal hemorrhaging (105.05A), as a consequence of 
cirrhosis and high pressure in the liver's portal venous system, may 
occur from varices (dilated veins in the esophagus or the stomach) 
or from portal hypertensive gastropathy (abnormal mucosal changes in 
the stomach). When gastrointestinal hemorrhaging is due to a cause 
other than CLD, we evaluate it under 105.02. The phrase ``consider 
under a disability for 1 year'' in 105.02 and 105.05A does not refer 
to the date on which your disability began, only to the date on 
which we must reevaluate whether your impairment(s) continues to 
meet a listing or is otherwise disabling. We determine the onset of 
your disability based on the facts of your case.
    b. Ascites or hydrothorax (105.05B) is a pathologic accumulation 
of fluid in the peritoneal cavity (ascites) or pleural space 
(hydrothorax). Ascites or hydrothorax may be diagnosed by removing 
some of the fluid with needle aspiration (paracentesis or 
thoracentesis), physical examination, or imaging. The most common 
causes of ascites are portal hypertension and low serum albumin 
resulting from CLD. We evaluate other causes of ascites and 
hydrothorax that are unrelated to CLD, such as congestive heart 
failure and cancer, under the listings in the affected body systems.
    c. Spontaneous bacterial peritonitis (SBP) (105.05C) is an acute 
bacterial infection of peritoneal fluid, and is most commonly 
associated with CLD. SBP is diagnosed by laboratory analysis of 
peritoneal fluid (obtained by paracentesis) that contains a 
neutrophil count (also called absolute neutrophil count) of at least 
250 cells/mm\3\. 105.05C is satisfied with one evaluation 
documenting peritoneal infection. We evaluate other causes of 
peritonitis that are unrelated to CLD, such as tuberculosis, 
malignancy, and perforated bowel, under the listings in the affected 
body systems.
    d. Hepatorenal syndrome (105.05D) is renal failure associated 
with CLD in the absence of underlying kidney pathology. Findings 
associated with hepatorenal syndrome include elevation of serum 
creatinine, sodium retention with low urinary sodium excretion, and 
oliguria (reduced output of urine). We evaluate renal dysfunction 
with known underlying kidney pathology, such as glomerulonephritis, 
tubular necrosis, and renal infections under the listings in 106.00.
    e. Hepatopulmonary syndrome (105.05E) is arterial deoxygenation 
(hypoxemia) due to intrapulmonary vascular dilation and 
arteriovenous shunting, associated with CLD. We evaluate pulmonary 
dysfunction with known underlying respiratory pathology, such as 
asthma, pneumonia, and pulmonary infections, under the listings in 
103.00.
    (i) Under 105.05E1, we require a resting arterial blood gas 
(ABG) measurement obtained while you are breathing room air; that 
is, without oxygen supplementation. The ABG report must include the 
PaO2 value, your name, the date of the test, 
and either the altitude or both the city and State of the test site.
    (ii) We will not purchase the specialized imaging techniques 
described in 105.05E2; however, if you have had the test(s) at a 
time relevant to your claim, we will make every reasonable effort to 
obtain the report.
    f. Hepatic encephalopathy (105.05F), also known as portosystemic 
encephalopathy, is a recurrent or chronic neuropsychiatric disorder 
associated with CLD.
    (i) Under 105.05F2, we require documentation of a mental 
impairment associated with hepatic encephalopathy. A mental 
impairment can include abnormal behavior, changes in mental status, 
or an altered state of consciousness. Reports of abnormal behavior 
may show that you are experiencing delusions, paranoia, or 
hallucinations. Reports of changes in mental status may show change 
in sleep patterns, personality or mood changes, poor concentration, 
or poor judgment or cognitive dysfunction (for example, impaired 
memory, poor problem-solving ability, or attention deficits). 
Reports of altered state of consciousness may show that you are 
experiencing confusion, delirium, or stupor.
    (ii) Signs and laboratory findings that document the severity of 
hepatic encephalopathy when not attributable to other causes may 
include a ``flapping tremor'' (asterixis), characteristic 
abnormalities found on an electroencephalogram (EEG), or abnormal 
serum albumin or coagulation values. We will not purchase an EEG; 
however, if you have had this test at a time relevant to your claim, 
we will make every reasonable effort to obtain the report for the 
purpose of establishing whether your impairment meets the criteria 
of 105.05F.
    (iii) We will not evaluate acute encephalopathy under 105.05F if 
it results from conditions other than CLD. For example, we will 
evaluate acute encephalopathy caused by vascular events under the 
listings in 111.00 and acute encephalopathy caused by cancer under 
the listings in 113.00.
    3. SSA CLD and SSA CLD-P scores (105.05G). Listing 105.05G1 
requires two SSA CLD scores, each requiring three laboratory values, 
or two SSA CLD-P scores, each requiring four parameters (three 
laboratory values and growth failure). The ``date of the SSA CLD 
score'' is the date of the earliest of the three laboratory values 
used for its calculation. The ``date of the SSA CLD-P score'' is the 
date of the earliest of the three laboratory values used for its 
calculation. For 105.05G1, the date of the second SSA CLD or SSA 
CLD-P score must

[[Page 35952]]

be at least 60 days after the date of the first SSA CLD or SSA CLD-P 
score and both scores must be within the required 12-month period. 
Listing 105.05G2 requires one SSA CLD-P score.
    a. SSA CLD score.
    (i) We calculate the SSA CLD score using a formula that includes 
three laboratory values: Serum creatinine (mg/dL), total bilirubin 
(mg/dL), and INR. The formula for the SSA CLD score calculation is:

9.57 x [loge(serum creatinine mg/dL)] + 3.78 x 
[loge(serum total bilirubin mg/dL)] + 11.2 x 
[loge(INR)] + 6.43

    (ii) When we indicate ``loge'' (also abbreviated 
``ln'') in the formula for the SSA CLD score calculation, we mean 
the ``base e logarithm'' or ``natural logarithm'' of the numerical 
laboratory value, not the ``base 10 logarithm'' or ``common 
logarithm'' (log) of the laboratory value, and not the actual 
laboratory value. For example, if a person has laboratory values of 
serum creatinine 2.0 mg/dL, serum total bilirubin 1.5 mg/dL, and INR 
1.0, we compute the SSA CLD score as follows:

9.57 x [loge(serum creatinine 2.0 mg/dL) = 0.693] + 3.78 
x [loge(serum total bilirubin 1.5 mg/dL) = 0.405] + 11.2 
x [loge(INR 1.0) = 0] + 6.43
= 6.63 + 1.53 + 0 + 6.43
= 14.6, which we round to an SSA CLD score of 15.

    (iii) For an SSA CLD score calculation, all of the required 
laboratory values (serum creatinine, serum total bilirubin, and INR) 
must have been obtained within a continuous 30-day period. We round 
any of the required laboratory values less than 1.0 up to 1.0 to 
calculate your SSA CLD score. If there are multiple laboratory 
values within the 30-day interval for any given laboratory test, we 
use the highest value to calculate your SSA CLD score. If you are in 
renal failure or on dialysis within a week of any serum creatinine 
test in the period used for the SSA CLD calculation, we will use a 
serum creatinine value of 4, which is the maximum serum creatinine 
level allowed in the calculation, to calculate your SSA CLD score. 
We will not use any INR values derived from testing done while you 
are on anticoagulant treatment in our SSA CLD calculation. We round 
the results of your SSA CLD score calculation to the nearest whole 
integer to arrive at your SSA CLD score.
    b. SSA CLD-P score
    (i) We calculate the SSA CLD-P scores using a formula that 
includes four parameters: Serum total bilirubin (mg/dL), INR, serum 
albumin (g/dL), and whether you have growth failure. The formula for 
the SSA CLD-P score calculation is:

4.80 x [loge(serum total bilirubin mg/dL)] + 18.57 x 
[loge(INR)] - 6.87 x [loge(serum albumin g/
dL)] + 6.67 if you have growth failure (<-2 standard deviations for 
weight or height)

    (ii) When we indicate ``loge'' in the formula for the 
SSA CLD-P score calculation, we mean the ``base e logarithm'' or 
``natural logarithm'' (loge) of a numerical laboratory 
value, not the ``base 10 logarithm'' or ``common logarithm'' (log) 
of the laboratory value, and not the actual laboratory value. For 
example, if a female child is 4.0 years old, has growth failure, and 
has laboratory values of serum total bilirubin 2.2 mg/dL, INR 1.0, 
and serum albumin 3.5 g/dL, we compute the SSA CLD-P score as 
follows:

4.80 x [loge(serum total bilirubin 2.2 mg/dL) = 0.788] + 
18.57 x [loge(INR 1.0) = 0] - 6.87 x 
[loge(serum albumin 3.5 g/dL) = 1.253] + 6.67
= 3.78 + 0 - 8.61 + 6.67
= 1.84, which we round to an SSA CLD-P score of 2.

    (iii) For an SSA CLD-P score calculation, all of the required 
laboratory values (serum total bilirubin, INR, and serum albumin) 
must have been obtained within a continuous 30-day period. We round 
any of the required laboratory values less than 1.0 up to 1.0 to 
calculate your SSA CLD-P score. If there are multiple laboratory 
values within the 30-day interval for any given laboratory test, we 
use the highest serum total bilirubin and INR values and the lowest 
serum albumin value to calculate the SSA CLD-P score. We will not 
use any INR values derived from testing done while you are on 
anticoagulant treatment in our SSA CLD-P calculation. We will not 
purchase INR values for children who have not attained age 12. If 
there is no INR value for a child under 12 within the applicable 
period, we will use an INR value of 1.1 to calculate the SSA CLD-P 
score. We round the results of your SSA CLD-P score calculation to 
the nearest whole integer to arrive at your SSA CLD-P score.
    (iv) The weight and length/height measurements used for the 
calculation must be obtained within the same 30-day period as the 
laboratory values.
    4. Extrahepatic biliary atresia (105.05H) presents itself in the 
first 2 months of life with persistent jaundice. To satisfy 105.05H, 
the diagnosis of extrahepatic biliary atresia must be confirmed by 
liver biopsy or intraoperative cholangiogram that shows obliteration 
of the extrahepatic biliary tree. Biliary atresia is usually treated 
surgically by portoenterostomy (for example, Kasai procedure). If 
this surgery is not performed in the first months of life or is not 
completely successful, liver transplantation is indicated. If you 
have received a liver transplant, we will evaluate your impairment 
under 105.09. The phrase ``consider under a disability for 1 year'' 
in 105.05H does not refer to the date on which your disability 
began, only to the date on which we must reevaluate whether your 
impairment(s) continues to meet a listing or is otherwise disabling. 
We determine the onset of your disability based on the facts of your 
case.
    D. What is inflammatory bowel disease (IBD), and how do we 
evaluate it under 105.06?
    1. IBD is a group of inflammatory conditions of the small 
intestine and colon. The most common IBD disorders are Crohn's 
disease and ulcerative colitis. Remissions and exacerbations of 
variable duration are a hallmark of IBD.
    2. We evaluate your signs and symptoms of IBD, such as diarrhea, 
fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever, 
nausea, vomiting, arthralgia, abdominal tenderness, and palpable 
abdominal mass (usually inflamed loops of bowel), when we assess the 
severity of your impairment(s).
    3. We consider other signs or laboratory findings of IBD that 
indicate malnutrition, such as anemia, edema, weight loss, or 
hypoalbuminemia, when we determine your ability to maintain adequate 
nutrition. We evaluate your inability to maintain adequate nutrition 
under 105.08.
    4. Examples of complications of IBD that may result in 
hospitalization include abscesses, intestinal perforation, toxic 
megacolon, infectious colitis, pyoderma gangrenosum, ureteral 
obstruction, primary sclerosing cholangitis, and hypercoagulable 
state (which may lead to thromboses or embolism). The three 
hospitalizations in 105.06C do not have to be for the same 
complication of IBD.
    E. What is short bowel syndrome (SBS), and how do we evaluate it 
under 105.07?
    1. SBS is a malabsorption disorder that occurs when congenital 
intestinal abnormalities, ischemic vascular insults (caused, for 
example, by volvulus or necrotizing enterocolitis), trauma, or IBD 
complications require(s) surgical resection of any amount of the 
small intestine, resulting in chronic malnutrition.
    2. We require a copy of the operative report that includes 
details of the surgical findings, or postoperative imaging 
indicating a resection of the small intestine. If we cannot get one 
of these reports, we need other medical reports that include details 
of the surgical findings. We also need medical documentation that 
you are dependent on daily parenteral nutrition to provide most of 
your nutritional requirements.
    F. How do we evaluate growth failure due to any digestive 
disorder under 105.08?
    1. To evaluate growth failure due to any digestive disorder, we 
require documentation of the laboratory findings of chronic 
nutritional deficiency described in 105.08A and the growth 
measurements in 105.08B within the same consecutive 12-month period. 
The dates of laboratory findings may be different from the dates of 
growth measurements.
    2. Under 105.08B, we evaluate a child's growth failure by using 
the appropriate table for age and gender.
    a. For children from birth to attainment of age 2, we use the 
weight-for-length table (see Table I or Table II).
    b. For children age 2 to attainment of age 18, we use the body 
mass index (BMI)-for-age table (see Table III or Table IV).
    c. BMI is the ratio of your weight to the square of your height. 
We calculate BMI using one of the following formulas:

English Formula

BMI = [Weight in Pounds/(Height in Inches x Height in Inches)] x 703

Metric Formulas

BMI = Weight in Kilograms/(Height in Meters x Height in Meters)
BMI = [Weight in Kilograms/(Height in Centimeters x Height in 
Centimeters)] x 10,000

    G. How do we evaluate digestive organ transplantation? If you 
receive a liver (105.09), small intestine (105.11), or pancreas

[[Page 35953]]

(105.12) transplant, we will consider you to be disabled under the 
listing for 1 year from the date of the transplant. After that, we 
evaluate your residual impairment(s) by considering the adequacy of 
your post-transplant function, the frequency and severity of any 
rejection episodes you have, complications in other body systems, 
and adverse treatment effects. People who receive digestive organ 
transplants generally have impairments that meet our definition of 
disability before they undergo transplantation. The phrase 
``consider under a disability for 1 year'' in 105.09, 105.11, and 
105.12 does not refer to the date on which your disability began, 
only to the date on which we must reevaluate whether your 
impairment(s) continues to meet a listing or is otherwise disabling. 
We determine the onset of your disability based on the facts of your 
case.
    H. How do we evaluate the need for supplemental daily enteral 
feeding via a gastrostomy? We evaluate the need for supplemental 
daily enteral feeding via a gastrostomy in children who have not 
attained age 3 under 105.10 regardless of the medical reason for the 
gastrostomy. After a child attains age 3, we evaluate growth failure 
due to any digestive disorder under 105.08, IBD requiring 
supplemental daily enteral or parenteral nutrition under 105.06, or 
other medical or developmental disorders under another digestive 
disorders listing or under a listing in an affected body system(s).
    I. How do we evaluate esophageal stricture or stenosis? 
Esophageal stricture or stenosis (narrowing) from congenital atresia 
(absence or abnormal closure of a tubular body organ) or destructive 
esophagitis may result in malnutrition or the need for gastrostomy 
placement, which we evaluate under 105.08 or 105.10. Esophageal 
stricture or stenosis may also result in complications such as 
pneumonias due to frequent aspiration, or difficulty in maintaining 
nutritional status short of listing level severity. While these 
individual complications usually do not meet the listing criteria, a 
combination of your impairments may medically equal a listing or 
functionally equal the listings.
    J. How do we evaluate your digestive disorder if there is no 
record of ongoing treatment? If there is no record of ongoing 
treatment despite the existence of a severe impairment(s), we will 
assess the severity and duration of your digestive disorder based on 
the current medical and other evidence in your case record. If there 
is no record of ongoing treatment, you may not be able to show an 
impairment that meets a digestive disorders listing, but your 
impairment may medically equal a listing, or be disabling based on 
our rules of functional equivalence.
    K. How do we evaluate your digestive disorder if there is 
evidence establishing a substance use disorder? If we find that you 
are disabled and there is medical evidence in your case record 
establishing that you have a substance use disorder, we will 
determine whether your substance use disorder is a contributing 
factor material to the determination of disability. See Sec.  
416.935 of this chapter. Digestive disorders resulting from drug or 
alcohol use are often chronic in nature and will not necessarily 
improve with cessation in drug or alcohol use.
    L. How do we evaluate digestive disorders that do not meet one 
of these listings?
    1. These listings are only examples of common digestive 
disorders that we consider severe enough to result in marked and 
severe functional limitations. If your impairment(s) does not meet 
the criteria of any of these listings, we must also consider whether 
you have an impairment(s) that satisfies the criteria of a listing 
in another body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec.  416.926 of this 
chapter. Digestive disorders may be associated with disorders in 
other body systems, and we consider the combined effects of multiple 
impairments when we determine whether they medically equal a 
listing. If your impairment(s) does not meet or medically equal a 
listing, we will also consider whether it functionally equals the 
listings. See Sec.  416.926a of this chapter. We use the rules in 
Sec.  416.994a of this chapter when we decide whether you continue 
to be disabled.
    105.01 Category of Impairments, Digestive Disorders
    105.02 Gastrointestinal hemorrhaging from any cause, requiring 
three blood transfusions of at least 10 cc of blood/kg of body 
weight per transfusion, within a consecutive 12-month period and at 
least 30 days apart. Consider under a disability for 1 year 
following the last documented transfusion; after that, evaluate the 
residual impairment(s).
    105.03-105.04 [Reserved]
    105.05 Chronic liver disease (CLD) (see 105.00C) with A, B, C, 
D, E, F, G, or H:
    A. Hemorrhaging from esophageal, gastric, or ectopic varices, or 
from portal hypertensive gastropathy (see 105.00C2a), documented by 
imaging (see 105.00B3); resulting in hemodynamic instability 
indicated by signs such as pallor (pale skin), diaphoresis (profuse 
perspiration), rapid pulse, low blood pressure, postural hypotension 
(pronounced fall in blood pressure when arising to an upright 
position from lying down, or syncope (fainting); and requiring 
hospitalization for transfusion of at least 10 cc of blood/kg of 
body weight. Consider under a disability for 1 year following the 
documented transfusion; after that, evaluate the residual 
impairment(s).

OR

    B. Ascites or hydrothorax not attributable to other causes (see 
105.00C2b), present on two evaluations within a consecutive 12-month 
period and at least 60 days apart. Each evaluation must document the 
ascites or hydrothorax by 1, 2, or 3:
    1. Paracentesis; or
    2. Thoracentesis; or
    3. Imaging or physical examination with a or b:
    a. Serum albumin of 3.0 g/dL or less; or
    b. INR of at least 1.5.

OR

    C. Spontaneous bacterial peritonitis (see 105.00C2c) documented 
by peritoneal fluid containing a neutrophil count of at least 250 
cells/mm\3\.

OR

    D. Hepatorenal syndrome (see 105.00C2d) documented by 1, 2, or 
3:
    1. Serum creatinine elevation of at least 2 mg/dL; or
    2. Oliguria with 24-hour urine output less than 1 mL/kg/hr; or
    3. Sodium retention with urine sodium less than 10 mEq per 
liter.

OR

    E. Hepatopulmonary syndrome (see 105.00C2e) documented by 1 or 
2:
    1. Arterial PaO2 measured by an ABG test, 
while at rest, breathing room air, less than or equal to:
    a. 60 mm Hg, at test sites less than 3,000 feet above sea level; 
or
    b. 55 mm Hg, at test sites from 3,000 through 6,000 feet above 
sea level; or
    c. 50 mm Hg, at test sites over 6,000 feet above sea level; or
    2. Intrapulmonary arteriovenous shunting as shown on contrast-
enhanced echocardiography or macroaggregated albumin lung perfusion 
scan.

OR

    F. Hepatic encephalopathy (see 105.00C2f) with documentation of 
abnormal behavior, cognitive dysfunction, changes in mental status, 
or altered state of consciousness (for example, confusion, delirium, 
stupor, or coma), present on two evaluations within a consecutive 
12-month period and at least 60 days apart and either 1 or 2:
    1. History of transjugular intrahepatic portosystemic shunt 
(TIPS) or other surgical portosystemic shunt; or
    2. One of the following on at least two evaluations at least 60 
days apart within the same consecutive 12-month period as in F:
    a. Asterixis or other fluctuating physical neurological 
abnormalities; or
    b. EEG demonstrating triphasic slow wave activity; or
    c. Serum albumin of 3.0 g/dL or less; or
    d. INR of 1.5 or greater.

OR

    G. SSA CLD or SSA CLD-P scores (see 105.00C3):
    1. For children age 12 or older, two SSA CLD or SSA CLD-P scores 
of at least 20 within a consecutive 12-month period and at least 60 
days apart; or
    2. For children who have not attained age 12, one SSA CLD-P 
score of at least 11.

OR

    H. Extrahepatic biliary atresia as diagnosed on liver biopsy or 
intraoperative cholangiogram (see 105.00C4). Consider under a 
disability for 1 year following diagnosis; after that, evaluate the 
residual impairment(s).
    105.06 Inflammatory bowel disease (IBD) (see 105.00D) documented 
by endoscopy, biopsy, imaging, or operative findings and 
demonstrated by A or B:
    A. Obstruction of stenotic areas (not adhesions) in the small 
intestine or colon with proximal dilatation, confirmed by imaging or 
in surgery, requiring two hospitalizations for intestinal 
decompression or for surgery, within a consecutive 12-month period 
and at least 60 days apart.

OR


[[Page 35954]]


    B. Two of the following occurring within a consecutive 12-month 
period and at least 60 days apart:
    1. Clinically documented tender abdominal mass palpable on 
physical examination with abdominal pain or cramping; or
    2. Perineal disease with a draining abscess or fistula; or
    3. Need for supplemental daily enteral nutrition via a 
gastrostomy or daily parenteral nutrition via a central venous 
catheter (see 105.10 for children who have not attained age 3).
    105.07 Short bowel syndrome (SBS) (see 105.00E) due to surgical 
resection of any amount of the small intestine, resulting in 
dependence on daily parenteral nutrition via a central venous 
catheter.
    105.08 Growth failure due to any digestive disorder (see 
105.00F), documented by A and B:
    A. Chronic nutritional deficiency present on two evaluations 
within a consecutive 12-month period and at least 60 days apart 
documented by 1 or 2:
    1. Anemia with hemoglobin less than 10.0 g/dL; or
    2. Serum albumin of 3.0 g/dL or less.

AND

    B. Growth failure as required in 1 or 2:
    1. For children from birth to attainment of age 2, three weight-
for-length measurements that are:
    a. Within a consecutive 12-month period; and
    b. At least 60 days apart; and
    c. Less than the third percentile values in Table I or Table II; 
or

                                   Table I--Males Birth to Attainment of Age 2
                                 [Third percentile values for weight-for-length]
----------------------------------------------------------------------------------------------------------------
                         Weight                             Weight
Length (centimeters)  (kilograms)  Length (centimeters)  (kilograms)  Length (centimeters)   Weight (kilograms)
----------------------------------------------------------------------------------------------------------------
               45.0   1.597                       64.5   6.132                       84.5                10.301
               45.5   1.703                       65.5   6.359                       85.5                10.499
               46.5   1.919                       66.5   6.584                       86.5                10.696
               47.5   2.139                       67.5   6.807                       87.5                10.895
               48.5   2.364                       68.5   7.027                       88.5                11.095
               49.5   2.592                       69.5   7.245                       89.5                11.296
               50.5   2.824                       70.5   7.461                       90.5                11.498
               51.5   3.058                       71.5   7.674                       91.5                11.703
               52.5   3.294                       72.5   7.885                       92.5                11.910
               53.5   3.532                       73.5   8.094                       93.5                12.119
               54.5   3.771                       74.5   8.301                       94.5                12.331
               55.5   4.010                       75.5   8.507                       95.5                12.546
               56.5   4.250                       76.5   8.710                       96.5                12.764
               57.5   4.489                       77.5   8.913                       97.5                12.987
               58.5   4.728                       78.5   9.113                       98.5                13.213
               59.5   4.966                       79.5   9.313                       99.5                13.443
               60.5   5.203                       80.5   9.512                      100.5                13.678
               61.5   5.438                       81.5   9.710                      101.5                13.918
               62.5   5.671                       82.5   9.907                      102.5                14.163
               63.5   5.903                       83.5   10.104                     103.5                14.413
----------------------------------------------------------------------------------------------------------------


                                 Table II--Females Birth to Attainment of Age 2
                                 [Third percentile values for weight-for-length]
----------------------------------------------------------------------------------------------------------------
                         Weight                             Weight
Length (centimeters)  (kilograms)  Length (centimeters)  (kilograms)  Length (centimeters)   Weight (kilograms)
----------------------------------------------------------------------------------------------------------------
               45.0   1.613                       64.5   5.985                       84.5                10.071
               45.5   1.724                       65.5   6.200                       85.5                10.270
               46.5   1.946                       66.5   6.413                       86.5                10.469
               47.5   2.171                       67.5   6.625                       87.5                10.670
               48.5   2.397                       68.5   6.836                       88.5                10.871
               49.5   2.624                       69.5   7.046                       89.5                11.074
               50.5   2.852                       70.5   7.254                       90.5                11.278
               51.5   3.081                       71.5   7.461                       91.5                11.484
               52.5   3.310                       72.5   7.667                       92.5                11.691
               53.5   3.538                       73.5   7.871                       93.5                11.901
               54.5   3.767                       74.5   8.075                       94.5                12.112
               55.5   3.994                       75.5   8.277                       95.5                12.326
               56.5   4.220                       76.5   8.479                       96.5                12.541
               57.5   4.445                       77.5   8.679                       97.5                12.760
               58.5   4.669                       78.5   8.879                       98.5                12.981
               59.5   4.892                       79.5   9.078                       99.5                13.205
               60.5   5.113                       80.5   9.277                      100.5                13.431
               61.5   5.333                       81.5   9.476                      101.5                13.661
               62.5   5.552                       82.5   9.674                      102.5                13.895
               63.5   5.769                       83.5   9.872                      103.5                14.132
----------------------------------------------------------------------------------------------------------------

    2. For children age 2 to attainment of age 18, three BMI-for-age 
measurements that are:
    a. Within a consecutive 12-month period; and
    b. At least 60 days apart; and
    c. Less than the third percentile value in Table III or Table 
IV.

[[Page 35955]]



                                 Table III--Males Age 2 to Attainment of Age 18
                                    [Third percentile values for BMI-for-age]
----------------------------------------------------------------------------------------------------------------
  Age (yrs. and mos.)      BMI     Age (yrs. and mos.)      BMI     Age (yrs. and mos.)             BMI
----------------------------------------------------------------------------------------------------------------
           2.0 to 2.1    14.5            10.11 to 11.2    14.3           14.9 to 14.10                    16.1
           2.2 to 2.4    14.4             11.3 to 11.5    14.4           14.11 to 15.0                    16.2
           2.5 to 2.7    14.3             11.6 to 11.8    14.5            15.1 to 15.3                    16.3
          2.8 to 2.11    14.2            11.9 to 11.11    14.6            15.4 to 15.5                    16.4
           3.0 to 3.2    14.1             12.0 to 12.1    14.7            15.6 to 15.7                    16.5
           3.3 to 3.6    14.0             12.2 to 12.4    14.8            15.8 to 15.9                    16.6
          3.7 to 3.11    13.9             12.5 to 12.7    14.9          15.10 to 15.11                    16.7
           4.0 to 4.5    13.8             12.8 to 12.9    15.0            16.0 to 16.1                    16.8
           4.6 to 5.0    13.7            12.10 to 13.0    15.1            16.2 to 16.3                    16.9
           5.1 to 6.0    13.6             13.1 to 13.2    15.2            16.4 to 16.5                    17.0
           6.1 to 7.6    13.5             13.3 to 13.4    15.3            16.6 to 16.8                    17.1
           7.7 to 8.6    13.6             13.5 to 13.7    15.4           16.9 to 16.10                    17.2
           8.7 to 9.1    13.7             13.8 to 13.9    15.5           16.11 to 17.0                    17.3
           9.2 to 9.6    13.8           13.10 to 13.11    15.6            17.1 to 17.2                    17.4
          9.7 to 9.11    13.9             14.0 to 14.1    15.7            17.3 to 17.5                    17.5
         10.0 to 10.3    14.0             14.2 to 14.4    15.8            17.6 to 17.7                    17.6
         10.4 to 10.7    14.1             14.5 to 14.6    15.9            17.8 to 17.9                    17.7
        10.8 to 10.10    14.2             14.7 to 14.8    16.0          17.10 to 17.11                    17.8
----------------------------------------------------------------------------------------------------------------


                                 Table IV--Females Age 2 to Attainment of Age 18
                                    [Third percentile values for BMI-for-age]
----------------------------------------------------------------------------------------------------------------
  Age (yrs. and mos.)      BMI     Age (yrs. and mos.)      BMI     Age (yrs. and mos.)             BMI
----------------------------------------------------------------------------------------------------------------
           2.0 to 2.2    14.1            10.8 to 10.10    14.0            14.3 to 14.5                    15.6
           2.3 to 2.6    14.0            10.11 to 11.2    14.1            14.6 to 14.7                    15.7
          2.7 to 2.10    13.9             11.3 to 11.5    14.2            14.8 to 14.9                    15.8
          2.11 to 3.2    13.8             11.6 to 11.7    14.3           14.10 to 15.0                    15.9
           3.3 to 3.6    13.7            11.8 to 11.10    14.4            15.1 to 15.2                    16.0
          3.7 to 3.11    13.6            11.11 to 12.1    14.5            15.3 to 15.5                    16.1
           4.0 to 4.4    13.5             12.2 to 12.4    14.6            15.6 to 15.7                    16.2
          4.5 to 4.11    13.4             12.5 to 12.6    14.7           15.8 to 15.10                    16.3
           5.0 to 5.9    13.3             12.7 to 12.9    14.8           15.11 to 16.0                    16.4
          5.10 to 7.6    13.2           12.10 to 12.11    14.9            16.1 to 16.3                    16.5
           7.7 to 8.4    13.3             13.0 to 13.2    15.0            16.4 to 16.6                    16.6
          8.5 to 8.10    13.4             13.3 to 13.4    15.1            16.7 to 16.9                    16.7
          8.11 to 9.3    13.5             13.5 to 13.7    15.2           16.10 to 17.0                    16.8
           9.4 to 9.8    13.6             13.8 to 13.9    15.3            17.1 to 17.3                    16.9
          9.9 to 10.0    13.7            13.10 to 14.0    15.4            17.4 to 17.7                    17.0
         10.1 to 10.4    13.8             14.1 to 14.2    15.5           17.8 to 17.11                    17.1
         10.5 to 10.7    13.9    .......................  ......  ......................  ......................
----------------------------------------------------------------------------------------------------------------

    105.09 Liver transplantation (see 105.00G). Consider under a 
disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).
    105.10 Need for supplemental daily enteral feeding via a 
gastrostomy (see 105.00H) due to any cause, for children who have 
not attained age 3; after that, evaluate the residual impairment(s).
    105.11 Small intestine transplantation (see 105.00G). Consider 
under a disability for 1 year from the date of the transplant; after 
that, evaluate the residual impairment(s).
    105.12 Pancreas transplantation (see 105.00G). Consider under a 
disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).
* * * * *

108.00 Skin Disorders

    A. Which skin disorders do we evaluate under these listings? We 
use these listings to evaluate skin disorders that result from 
hereditary, congenital, or acquired pathological processes. We 
evaluate genetic photosensitivity disorders (108.07), burns 
(108.08), and chronic conditions of the skin or mucous membranes 
such as ichthyosis, bullous disease, dermatitis, psoriasis, and 
hidradenitis suppurativa (108.09).
    B. What are our definitions for the following terms used in this 
body system?
    1. Assistive device(s): An assistive device, for the purposes of 
these listings, is any device that is used to improve stability, 
dexterity, or mobility. An assistive device can be hand-held, such 
as a cane(s), a crutch(es), or a walker; or worn, such as a 
prosthesis or an orthosis.
    2. Chronic skin lesions: Chronic skin lesions can have recurrent 
exacerbations. They can occur despite prescribed medical treatment. 
These chronic skin lesions can develop on any part of your body, 
including upper extremities, lower extremities, palms of your hands, 
soles of your feet, the perineum, inguinal (groin) region, and 
axillae (underarms). Chronic skin lesions may result in functional 
limitations as described in 108.00D2.
    3. Contractures: Contractures are permanent fibrous scar tissue 
resulting in tightening and thickening of skin that prevents normal 
movement of the damaged area. They can develop on any part of your 
musculoskeletal system, including upper extremities, lower 
extremities, palms of your hands, soles of your feet, the perineum, 
inguinal (groin) region, and axillae (underarms). Contractures may 
result in functional limitations as described in 108.00D2.
    4. Documented medical need: When we use the term ``documented 
medical need,'' we mean that there is evidence from your medical 
source(s) in the medical record that supports your need for an 
assistive device (see Sec.  416.913 of this chapter). The evidence 
must include documentation from your medical source(s) describing 
any limitation(s) in your upper or lower extremity functioning

[[Page 35956]]

that supports your need for the assistive device, and describing the 
circumstances for which you need it. The evidence does not have to 
include a specific prescription for the device.
    5. Fine and gross movements: Fine movements, for the purposes of 
these listings, involve use of your wrists, hands, and fingers; such 
movements include picking, pinching, manipulating, and fingering. 
Gross movements involve use of your shoulders, upper arms, forearms, 
and hands; such movements include handling, gripping, grasping, 
holding, turning, and reaching. Gross movements also include 
exertional activities such as lifting, carrying, pushing, and 
pulling. Evaluation of fine and gross movements is dependent on your 
age.
    6. Surgical management: For the purposes of these listings, 
surgical management includes the surgery(-ies) itself, as well as 
various post-surgical procedures, surgical complications, infections 
or other medical complications, related illnesses, or related 
treatments that delay a person's attainment of maximum benefit from 
surgery.
    C. What evidence do we need to evaluate your skin disorder?
    1. To establish the presence of a skin disorder as a medically 
determinable impairment, we need objective medical evidence from an 
acceptable medical source who has examined you for the disorder.
    2. We will make every reasonable effort to obtain your medical 
history, treatment records, and relevant laboratory findings, but we 
will not purchase genetic testing.
    3. When we evaluate the presence and severity of your skin 
disorder(s), we generally need information regarding:
    a. The onset, duration, and frequency of exacerbations;
    b. The prognosis of your skin disorder;
    c. The location, size, and appearance of lesions and 
contractures;
    d. Your history of familial incidence; exposure to toxins, 
allergens or irritants; seasonal variations; and stress factors;
    e. Your ability to function outside of a highly protective 
environment;
    f. Laboratory findings (for example, a biopsy obtained 
independently of Social Security disability evaluation or results of 
blood tests);
    g. Evidence from other medically acceptable methods consistent 
with the prevailing state of medical knowledge and clinical 
practice; and
    h. Statements you or others make about your disorder(s), your 
restrictions, and your daily activities.
    D. How do we evaluate the severity of skin disorders?
    1. General. We evaluate the severity of skin disorders based on 
the site(s) of your chronic skin lesions or contractures, functional 
limitations caused by your signs and symptoms (including pain) (see 
108.00D2), and how your prescribed treatment affects you. We 
consider the frequency and severity of your exacerbations, how 
quickly they resolve, and how you function between exacerbations, to 
determine whether your skin disorder meets or medically equals a 
listing. If there is no record of ongoing medical treatment for your 
disorder, we will follow the guidelines in 108.00D6. We will 
determine the extent and kinds of evidence we need from medical and 
non-medical sources based on the individual facts about your 
disorder. For our basic rules on evidence, see Sec. Sec.  416.912, 
416.913, and 416.920b of this chapter. For our rules on evaluating 
your symptoms, see Sec.  416.929 of this chapter.
    2. Limitation(s) of physical functioning due to skin disorders.
    a. Skin disorders may be due to chronic skin lesions (see 
108.00B2) or contractures (see 108.00B3), and may cause pain or 
restrict movement, which can limit your ability to initiate, 
sustain, and complete age-appropriate activities. For example, skin 
lesions in the axilla may limit your ability to raise or reach with 
the affected arm, or lesions in the inguinal region may limit your 
ability to ambulate, sit, or lift and carry. To evaluate your skin 
disorder(s) under 108.07B, 108.08, and 108.09, we require medically 
documented evidence of physical limitation(s) of functioning related 
to your disorder. The decrease in physical function must have 
lasted, or can be expected to last, for a continuous period of at 
least 12 months (see Sec.  416.909 of this chapter). Xeroderma 
pigmentosum is the only skin disorder that does not include 
functional criteria because the characteristics and severity of the 
disorder itself are sufficient to meet the criteria in 108.07A.
    b. The functional criteria require impairment-related physical 
limitations in using upper or lower extremities that have lasted, or 
can be expected to last, for a continuous period of at least 12 
months, medically documented by one of the following:
    (i) Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
age-appropriate activities involving fine and gross movements;
    (ii) Inability to use one upper extremity to independently 
initiate, sustain, and complete age-appropriate activities involving 
fine and gross movements due to chronic skin lesions or 
contractures, and a documented medical need for a one-handed 
assistive device that requires the use of your other upper 
extremity; or
    (iii) Inability to stand up from a seated position and maintain 
an upright position to the extent you can independently initiate, 
sustain, and complete age-appropriate activities due to chronic skin 
lesions or contractures affecting at least two extremities 
(including when the limitations are due to involvement of the 
perineum or the inguinal region); or
    (iv) Inability to maintain an upright position while standing or 
walking, to independently initiate, sustain, and complete age-
appropriate activities due to chronic skin lesions or contractures 
affecting both lower extremities (including when the limitations are 
due to involvement of the perineum or the inguinal region).
    3. Frequency of exacerbations due to chronic skin lesions. A 
skin disorder resulting in chronic skin lesions (see 108.00B2) may 
have frequent exacerbations severe enough to meet a listing even if 
each individual skin lesion exacerbation did not last for an 
extended amount of time. We will consider the frequency, severity, 
and duration of skin lesion exacerbations; how quickly they resolve; 
and how you function in the time between skin lesion exacerbations, 
to determine whether your skin disorder meets or medically equals a 
listing.
    4. Symptoms (including pain). Your symptoms may be an important 
factor in our determination of whether your skin disorder(s) meets 
or medically equals a listing. We consider your symptoms only when 
you have a medically determinable impairment(s) that could 
reasonably be expected to produce the symptoms. See Sec.  416.929 of 
this chapter.
    5. Treatment.
    a. General. Treatments for skin disorders may have beneficial or 
adverse effects, and responses to treatment vary from person to 
person. Your skin disorder's response to treatment may vary due to 
treatment resistance or side effects that can result in functional 
limitations. We will evaluate all of the effects of treatment 
(including surgical treatment, medications, and therapy) on the 
symptoms, signs, and laboratory findings of your skin disorder, and 
on your ability to function.
    b. Despite adherence to prescribed medical treatment for 3 
months. Under 108.09, we require that your symptoms persist 
``despite adherence to prescribed medical treatment for 3 months.'' 
This requirement means that you must have taken prescribed 
medication(s) or followed other medical treatment prescribed by a 
physician for 3 consecutive months. Treatment or effects of 
treatment may be temporary. In most cases, sufficient time must 
elapse to allow us to evaluate your response to treatment, including 
any side effects. For our purposes, ``sufficient time'' means a 
period of at least three months. If your treatment has not lasted 
for at least 3 months, we will follow the rules in 108.00D6a. To 
evaluate the severity of physical limitations due to your skin 
disorder(s), we require medically documented evidence of disorder-
related physical limitation(s) of functioning that has lasted, or 
can be expected to last, for a continuous period of at least 12 
months. See Sec.  416.909 of this chapter. The 3 months adherence to 
prescribed medical treatment must be within the period of at least 
12 months that we use to evaluate severity.
    c. Treatment with PUVA (psoralen and ultraviolet A (UVA) light) 
or biologics. If you receive additional treatment with PUVA or 
biologics to treat your skin disorder(s), we will defer adjudication 
of your claim for 6 months from the start of treatment with PUVA or 
biologics to evaluate the effectiveness of these treatments unless 
we can make a fully favorable determination or decision on another 
basis.
    6. No record of ongoing treatment.
    a. Despite having a skin disorder, you may not have received 
ongoing treatment, may have just begun treatment, may not have 
access to prescribed medical treatment, or may not have an ongoing 
relationship with the medical community. In any of these situations, 
you will not have a longitudinal

[[Page 35957]]

medical record for us to review when we evaluate your disorder. In 
some instances, we may be able to assess the severity and duration 
of your skin disorder based on your medical record and current 
evidence alone. We may ask you to attend a consultative examination 
to determine the severity and potential duration of your skin 
disorder (see Sec.  416.919a of this chapter).
    b. If, for any reason, you have not received treatment, your 
skin disorder cannot meet the criteria for 108.09. If the 
information in your case record is not sufficient to show that you 
have a skin disorder that meets the criteria of one of the skin 
disorders listings, we will follow the rules in 108.00I.
    E. How do we evaluate genetic photosensitivity disorders under 
108.07? Genetic photosensitivity disorders are disorders of the skin 
caused by an increase in the sensitivity of the skin to sources of 
ultraviolet light, including sunlight.
    1. Xeroderma pigmentosum (XP) (108.07A). XP is a genetic 
photosensitivity disorder with lifelong hypersensitivity to all 
forms of ultraviolet light. Laboratory testing confirms the 
diagnosis by documenting abnormalities in the body's ability to 
repair DNA (deoxyribonucleic acid) mutations after ultraviolet light 
exposure. Your skin disorder meets the requirements of 108.07A if 
you have clinical and laboratory findings supporting a diagnosis of 
XP (see 108.00E3).
    2. Other genetic photosensitivity disorders (108.07B). The 
effects of other genetic photosensitivity disorders may vary and may 
not persist over time. To meet the requirements of 108.07B, a 
genetic photosensitivity disorder other than XP must be established 
by clinical and laboratory findings (see 108.00C) and either must 
result in chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3) that result in functional limitations (108.00D), or must 
result in the inability to function outside of a highly protective 
environment. Some genetic photosensitivity disorders can have very 
serious effects on other body systems, especially special senses and 
speech, neurological, mental, and cancer. We will evaluate your 
disorder(s) under the listings in 102.00, 111.00, 112.00, or 113.00, 
as appropriate.
    3. What evidence do we need to document that you have XP or 
another genetic photosensitivity disorder? We will make a reasonable 
effort to obtain evidence of your disorder(s), but we will not 
purchase genetic testing. When the results of genetic tests are part 
of the existing evidence in your case record, we will evaluate the 
test results with all other relevant evidence. We need the following 
clinical and laboratory findings to document that you have XP or 
another genetic photosensitivity disorder:
    a. A laboratory report of a definitive genetic laboratory test 
documenting appropriate chromosomal changes, including abnormal DNA 
repair or another DNA abnormality specific to your type of 
photosensitivity disorder, signed by an acceptable medical source 
(AMS); or
    b. A laboratory report of a definitive test that is not signed 
by an AMS, and a report from an AMS stating that you have undergone 
definitive genetic laboratory studies documenting appropriate 
chromosomal changes, including abnormal DNA repair or another DNA 
abnormality specific to your type of photosensitivity disorder; or
    c. If we do not have a laboratory report of a definitive test, 
we need documentation from an AMS that an appropriate laboratory 
analysis or other diagnostic method(s) confirms a positive diagnosis 
of your skin disorder. This documentation must state that you had 
the appropriate definitive laboratory test(s) for diagnosing your 
disorder and provide the results, or explain how another diagnostic 
method(s), consistent with the prevailing state of medical knowledge 
and clinical practice, established your diagnosis.
    4. Inability to function outside of a highly protective 
environment means that you must avoid exposure to ultraviolet light 
(including sunlight passing through windows and light from similar 
unshielded light sources), wear protective clothing and eyeglasses, 
and use opaque broad-spectrum sunscreens in order to avoid skin 
cancer or other serious effects.
    F. How do we evaluate burns under 108.08?
    1. Electrical, chemical, or thermal burns frequently affect 
other body systems; for example, musculoskeletal, special senses and 
speech, respiratory, cardiovascular, genitourinary, neurological, or 
mental. We evaluate burns in the same way we evaluate other 
disorders that can affect the skin and other body systems, using the 
listing for the predominant feature of your disorder. For example, 
if your soft tissue injuries resulting from burns are under surgical 
management (as defined in 108.00B6), we will evaluate your disorder 
under the listings in 101.00.
    2. We evaluate third-degree burns resulting in contractures (see 
108.00B3) that have been documented by an acceptable medical source 
to have reached maximum therapeutic benefit and therefore are no 
longer receiving surgical management, under 108.08. To be disabling, 
these burns must result in functional limitation(s) (see 108.00D2) 
that has lasted or can be expected to last for a continuous period 
of at least 12 months.
    G. How do we evaluate chronic conditions of the skin or mucous 
membranes under 108.09? We evaluate skin disorders that result in 
chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) 
under 108.09. These disorders must result in chronic skin lesions or 
contractures that continue to persist despite adherence to 
prescribed medical treatment for 3 months (see 108.00D5b) and cause 
functional limitations (see 108.00D2). Examples of skin disorders 
evaluated under this listing are ichthyosis, bullous diseases (such 
as pemphigus, epidermolysis bullosa, and dermatitis herpetiformis), 
chronic skin infections, dermatitis, psoriasis, and hidradenitis 
suppurativa.
    H. How do we evaluate disorders in other body systems that 
affect the skin? When your disorder(s) in another body system 
affects the skin, we first evaluate the predominant feature of your 
disorder(s) under the appropriate body system. Examples of disorders 
in other body systems that affect the skin include the following:
    1. Tuberous sclerosis. The predominant functionally limiting 
features of tuberous sclerosis are seizures and intellectual 
disability or other mental disorders. We evaluate these features 
under the listings in 111.00 or 112.00, as appropriate.
    2. Malignant tumors of the skin. Malignant tumors of the skin 
(for example, malignant melanomas) are cancers, or malignant 
neoplastic diseases, that we evaluate under the listings in 113.00.
    3. Immune system disorders. We evaluate skin manifestations of 
immune system disorders such as systemic lupus erythematosus, 
scleroderma, psoriasis, and human immunodeficiency virus (HIV) 
infection under the listings in 114.00.
    4. Head or facial disfigurement or deformity, and other physical 
deformities caused by skin disorders. A head or facial disfigurement 
or deformity may result in loss of your sight, hearing, speech, or 
ability to chew. In addition to head and facial disfigurement and 
deformity, other physical deformities may result in associated 
psychological problems (for example, depression). We evaluate the 
effects of head or facial disfigurement or deformity, or other 
physical deformities caused by skin disorders under the listings in 
101.00, 102.00, 105.00, or 112.00, as appropriate.
    5. Porphyria. We evaluate erythropoietic protoporphyria under 
the listings in 107.00.
    6. Hemangiomas. We evaluate hemangiomas associated with 
thrombocytopenia and hemorrhage (for example, Kasabach-Merritt 
syndrome) involving coagulation defects under the listings in 
107.00. When hemangiomas impinge on vital structures or interfere 
with functioning, we evaluate their primary effects under the 
listings in the appropriate body system.
    I. How do we evaluate skin disorders that do not meet one of 
these listings?
    1. These listings are only examples of common skin disorders 
that we consider severe enough to result in marked and severe 
limitations. If your impairment(s) does not meet the criteria of any 
of these listings, we must also consider whether you have an 
impairment(s) that satisfies the criteria of a listing in another 
body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec.  416.926 of this 
chapter. If your impairment(s) does not meet or medically equal a 
listing, we will also consider whether your impairment(s) 
functionally equals the listings. See Sec.  416.926a of this 
chapter. We use the rules in Sec.  416.994a of this chapter when we 
decide whether you continue to be disabled.
    108.01 Category of Impairments, Skin Disorders
    108.02-108.06 [Reserved]
    108.07 Genetic photosensitivity disorders, established as 
described in 108.00E. The requirements of this listing are met if 
either paragraph A or paragraph B is satisfied.
    A. Xeroderma pigmentosum (see 108.00E1).

OR

    B. Other genetic photosensitivity disorders (see 108.00E2) with 
either 1 or 2:
    1. Chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3) that cause an

[[Page 35958]]

inability to function outside of a highly protective environment 
(see 108.00E4); or
    2. Chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3) that cause functional limitations (see 108.00D2) due to 
limitation(s) from your skin condition, such as pain, as evidenced 
by:
    a. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
age-appropriate activities involving fine and gross movements; or
    b. Inability to use one upper extremity to independently 
initiate, sustain, and complete age-appropriate activities involving 
fine and gross movements (due to chronic skin lesions or 
contractures), and a documented medical need for a one-handed 
assistive device that requires the use of your other upper 
extremity; or
    c. Inability to stand up from a seated position and maintain an 
upright position to the extent you can independently initiate, 
sustain, and complete age-appropriate activities due to chronic skin 
lesions or contractures affecting at least two extremities 
(including when the limitations are due to involvement of the 
perineum or the inguinal region); or
    d. Inability to maintain an upright position while standing or 
walking, to independently initiate, sustain, and complete age-
appropriate activities due to chronic skin lesions or contractures 
affecting both lower extremities (including when the limitations are 
due to involvement of the perineum or the inguinal region).
    108.08 Burns (see 108.00F). Third-degree burns that do not 
require continuing surgical management, or that have been documented 
by an acceptable medical source to have reached maximum therapeutic 
benefit and are no longer receiving surgical management, resulting 
in chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3) that cause functional limitations (see 108.00D2) due to 
limitation(s), such as pain, from your skin condition, as evidenced 
by:
    A. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
age-appropriate activities involving fine and gross movements.

OR

    B. Inability to use one upper extremity to independently 
initiate, sustain, and complete age-appropriate activities involving 
fine and gross movements (due to chronic skin lesions or 
contractures), and a documented medical need for a one-handed 
assistive device that requires the use of your other upper 
extremity.

OR

    C. Inability to stand up from a seated position and maintain an 
upright position to the extent you can independently initiate, 
sustain, and complete age-appropriate activities due to chronic skin 
lesions or contractures affecting at least two extremities 
(including when the limitations are due to involvement of the 
perineum or the inguinal region).

OR

    D. Inability to maintain an upright position while standing or 
walking, to independently initiate, sustain, and complete age-
appropriate activities due to chronic skin lesions or contractures 
affecting both lower extremities (including when the limitations are 
due to involvement of the perineum or the inguinal region).
    108.09 Chronic conditions of the skin or mucous membranes (see 
108.00G) resulting in:
    A. Chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3); chronic pain; or other physical limitation(s); that 
persist despite adherence to prescribed medical treatment for 3 
months (see 108.00D5b), causing functional limitations (see 
108.00D2) due to limitation(s), such as pain, from your skin 
condition.

AND

    B. Impairment-related significant limitation demonstrated by 1, 
2, 3, or 4:
    1. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
age-appropriate activities involving fine and gross movements; or
    2. Inability to use one upper extremity to independently 
initiate, sustain, and complete age-appropriate activities involving 
fine and gross movements (due to chronic skin lesions or 
contractures), and a documented medical need for a one-handed 
assistive device that requires the use of your other upper 
extremity; or
    3. Inability to stand up from a seated position and maintain an 
upright position to the extent you can independently initiate, 
sustain, and complete age-appropriate activities due to chronic skin 
lesions or contractures affecting at least two extremities 
(including when the limitations are due to involvement of the 
perineum or the inguinal region); or
    4. Inability to maintain an upright position while standing or 
walking, to independently initiate, sustain, and complete age-
appropriate activities due to chronic skin lesions or contractures 
affecting both lower extremities (including when the limitations are 
due to involvement of the perineum or the inguinal region).
* * * * *
[FR Doc. 2019-15554 Filed 7-24-19; 8:45 am]
 BILLING CODE P